NEW JERSEY CENTER FOR BIOMATERIALS

Celebrating 25 years of Research and Development Excellence

www.njbiomaterials.org

2016/2017

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For 25 years, the New Jersey Center for Biomaterials has drawn its financial support from a wide variety of institutional, federal, state, foundation, individual and private industry supporters.

SOURCES OF FUNDING 1991 - 2016

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Foundations and Individuals / Whitaker Foundation, Musculoskeletal Foundation, Osteoscience Foundation, NJ Health Foundation, the Rutgers Class of 1954

NSF National Science Foundation

DoD Department of Defense

$ Million

US Army Medical Research and Materiel Command has supported major collabo-

(p. 6, 7, 16)

Partnerships for Innovation awards supported academic-industry projects to accelerate biomaterials development.

State of New Jersey / NJCBM was formally established with a major Center of Excellence award from the New Jersey Commission on Science and Technology in 1997.

Industry / Dozens of companies have collaborated with NJCBM through research and service agreements, and licensing of technology. (p.22,23)

Seed Funding / NJCBM got its start through seed funding by the public universities of New Jersey in 1991.

NIHNIH's National Institute for Biomedical Imaging and Bioengineering has supported Postdoctoral Training and Biomedical Technology centers at NJCBM since 2002. (p.8, 15, 18)

On this 25th anniversary, we are proud to report that the center has raised more than $100 million.

National Institutes of Health

rative efforts led by NJCBM since 2014.

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DIRECTOR’S MESSAGE

Welcome to the New Jersey Center for Biomaterials, NJCBM. We are an interdisciplinary research center based at Rutgers, The State University of New Jersey - that spans academia, industry and government. As biomaterials scientists, our goal is to conduct state-of-the-art research in biomaterials science and engineering and to improve health care and the quality of life by developing advanced biomedical products for tissue repair and replacement, and the delivery of pharmaceutical agents. Our technologies have been translated into pre-clinical and clinical products, including an antimicrobial implant for the prevention of pacemaker infections, a surgical mesh for hernia repair, a fully resorbable and x-ray visible coronary stent, a bone regeneration scaffold and an ocular drug delivery system for the treatment of inflammatory eye disorders.

Our leading research program, RESBIO, integrates the work of chemists, materials scientists, biologists and biomedical engineers toward development of bioactive scaffolds for tissue engineering. Our postdoctoral training program creates a geographically disbursed training community focused on translational research for regenerative medicine.

At the most fundamental level, our scientific work at the Center begins with polymer design and synthesis. Here, combinatorial libraries are designed to elucidate complex structure-property-performance relationships. Identification of these relationships may enable the rational design of new biomaterials.

The synthesized polymers then integrate with or compose a medical application in either bone or nerve regeneration through our fabrication and engineering prototyping protocols. This results in the development of biomaterials and bioactive scaffolds based on combinatorial and computational approaches to enhance cellular activity.

Finally, the integration of synthetic polymers into living systems requires the study of cell-material interactions. Our scientists are elucidating the signaling mechanisms that guide cellular response to specific scaffold properties.

NJCBM also reaches beyond the USA to work with scholarly biomaterials societies across the world to advance the field and to promote and develop new collaborations through international student exchange programs. Thus, we build for the global future where research partners may be located not only in different countries, but on different continents.

Indeed, such a global outlook on the future of biomaterials science feeds into NJCBM’s research collaborations and its interactions with industrial partners. Our industry network and our Center for Dermal Research are the two primary entry points for companies who wish to work with us. Our NIH funded RESBIO program drives many of the academic collaborations. I invite you to contact me to explore the many ways in which we can work together.

Sincerely, Joachim Kohn, Ph.D., FBSEDirector, the New Jersey Center for Biomaterials Board of Governors Professor, Rutgers, The State University of New Jerseyemail:kohn@dls.rutgers.eduBone regeneration scaffold in the skull

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Joachim Kohn, PhD, FBSE, Director

BREAKTHROUGH POLYMER DESIGNS

The scientists at the NJCBM are a highly interdisciplinary group consisting of polymer chemists, material scientists, cell and stem cell biologists, biomedical engineers and industrial scientists with expertise in product development. In conducting their research, the faculty and students at the NJCBM combine excellence in basic science with highly focused application-driven research.

Tyrosine-derived PolymersPoly(amino acid)s are conventional polymers made of natural amino acids that are usually intractable materials with limited practical applications. However, by modifying the way the amino acids are incorporated into the polymer back-bone, Joachim Kohn and his students developed an entirely new class of polymers that combine the non-toxicity of natural amino acids with the favorable materials properties of common engineering plastics. In this way, tyrosine-de-rived poly(carbonate-amide)s, polyarylates, and most recently new poly(carbonate- ester)s were identified and further optimized for use in a wide range of medical implants. Not only are these degradable polymers strong enough to do the job, but also they can be rendered visible under x-ray during implantation.

Radio-opaque Polymer Biomaterials Synthetic degradable polymers are used as medical implants in a wide range of applications, such as orthopedic bone fixation devices, drug delivery systems, cardiovascular implants, and scaffolds for the regeneration/engineering of tissue. Such polymers, when used as implants are non-traceable without invasive procedures. A radio-opaque polymer offers the unique advantage of being traceable via routine X-ray imaging. The fate of such an implant through various stages of its use can be followed without requiring invasive surgery. Such a radio-opaque polymer was developed at the NJCBM and has since been licensed by REVA Medical.

Ultrastrong PolymersPolymers are needed that have high modulus (> 10 GPa) and high strength (> 200 MPa) for applications such as bone repair, and ligament and meniscus replacement. NJCBM has led development of polymer compositions to fulfill this need. One composition, a polyarylate, has been successfully tested for ligament and meniscus application. Improving this composition, by controlling the degradability is being achieved by expanding the current library of polyarylates to include other polymer chemistries, and by exploring a new library of polyesters and aromatic-aliphatic poly(tyrosol carbonate)s. These compositions are expected to achieve modulus and strength higher than that of polymers currently available for biomedical applications.

Ultraflexible PolymersHighly elastic materials that are biocompatible and match the characteristics of the tissue at the implantation site are being developed as scaffolds for regenerating injured or diseased blood vessels and muscles. A key requirement for such application is high degree of elasticity and shape-memory, i.e., the material has to recover its shape completely after significant elongation of ~100%. Such materials are needed in devices used for vascular stents, and in mimicking muscles. Our laboratory has developed candidate polymers for these applications. These are based on the highly elastic poly(trimethylene carbonate) and tyrosine-derived polycarbonates. These polymers have a strain to break ~ 1000%, and have very good recovery after 100% strain. These materials possess an added advantage over competing materials in that they can be designed to degrade at a desired rate for a specific application.

Ultrafast degradable PolymersMaterials that can be resorbed within hours, ultrafast degradable polymers, are being sought for application such as cortical neural prosthesis. We have recently developed one such polymer based on our library of tyrosine-derived terpolymers. These polymers contain either poly(ethylene glycol) (PEG) or poly(trimethylene carbonate) (PTMC), as the non-tyrosine segments. The in vivo tissue response to both polymers used as intraparenchymal cortical devices was compared to poly(lactic-co-glycolic acid) (PLGA). The fast degrading tyrosine-derived terpolymer that is also fast resorbing, significantly reduced both the glial response in the implantation site and the neuronal exclusion zone. Such polymers allow for brain tissue recovery, thus render them suitable for neural interfacing applications.

RU/NJCBM 2016

Bone regeneration scaffoldsUsing a combination of porogen leaching and phase separation, a new fabrication technology for bone regeneration scaffolds was developed. These scaffolds feature a bimodal distribution of macropores and micropores. Together with the use of a highly osteoconductive polymer composition, this architecture results in effective and rapid bone formation in vivo. The scaffolds have been competitively evaluated against several clinically used bone void fillers. Extensive sets of test data in the rabbit calvaria critical size defect model and more recently, in the goat calvaria critical size defect model, confirm the promise of these new scaffolds for use in new bone regeneration therapies.

APPLIED RESEARCH IN TISSUE ENGINEERING

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Bone fixation devicesResearchers at the NJCBM have fabricated new bone fixation devices including anchors for rotator cuff repair and other tendon and ligament reconstructions. These devices are made of polymers that are highly bone compatible, osteoconductive and that degrade into non-acidic degradation products. These devices avoid the late inflammation response sometimes seen with PGA- or PLA-based implants. Pins, screws, intramedullary rods, and plates have been fabricated using extrusion of injection molding. Animal studies have confirmed that these devices are highly compatible with bone tissue.

Resorbable bone fixation screwBiodegradable screws, to fix severe fractures as well as bioerodible scaffolds – a temporary support into which cells can grow and develop into functional tissue - encourage the growth of new bone after surgery. These products are close to commercialization.

Bone fixation devices (plates, rods, pins, screws)

a. Bone regeneration scaffolds, b. Porous scaffold produced by phase separation, freeze drying, salt leaching, c. Illuminated tyrosine derived polycarbonate scaffold with beta-tricalcium phosphate composite scaffold

a. b. c.

APPLIED RESEARCH IN TISSUE ENGINEERING AND DRUG DELIVERY

Conduits for peripheral nerve repairScientists at the NJCBM are developing flexible, kink-resistant, porous nerve guides. The nerve conduits are fabricated by tubular braiding of tyrosine-derived polycarbonate fibers. First, polymer powder is melt extruded using an industrial scale extruder to form fibers. Fibers are then twisted and braided over a mandrel with an outer diameter matching that of native nerve. To date, bench-top studies and in vivo studies in rodent and porcine models have confirmed functionality and utility of braided nerve conduits.

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Resorbable ophthalmic drug delivery systemAn ocular drug-delivery system - a device just slightly larger, and significantly slimmer, than average pencil point - was developed to relieve those that suffer from chronically dry eyes. It can be implanted against the white of the eye where it will deliver a steady stream of medication for about six to nine months before being resorbed into the body.

Scanning electron micrograph of three braided 1.5 mm ID uncoated nerve conduit made from

E1001(1k) (Scale bars = 1 mm.)Braided conduits as long as 8-9 cm, bent

on wires are extremely flexible and kink-free.

Nanoparticles for drug deliveryScientists at NJCBM have also developed a new type of degradable nanoparticular carrier, referred to as TyroSpheres. TyroSpheres are formed when tyrosine-derived ABA-type triblock copolymers are allowed to self-assemble in aqueous media. In the presence of hydrophobic drugs, these drugs are incorporated into the TyroSphere during the self-assembly process. TyroSpheres have an average diameter of 80 nm. Due to an extremely low critical aggregation concentration (CAC), TyroSpheres are stable when highly diluted. Over 20 different drugs (cancer therapeutics, vitamins, nutraceuticals, natural products, antimicrobial agents, fluorescent model compounds) have been formulated in TyroSpheres. Several papers describe the anticancer activity and toxicity benefits of paclitaxel-loaded TyroSpheres in comparison to the clinically used Cremophor-Paclitaxel formulation. Additional publications describe the advantages of topical applications of drug-loaded TyroSpheres in several animal models.

Transmission electron micrograph of tyrosine-derived polymeric nanospheres dispersed in buffer and dried on gold grids. Negative staining with uranyl acetate was applied. Scale bar = 100 nm.

These nanospheres self assemble, making it possible to use a very cost-effective, reagent free manufacturing process

NJCBM PRODUCTS USED IN THE CLINIC

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Synthetic biodegradable polymers produced at NJCBM have been successfully translated into implantable devices. 70 US patents have been issued on novel biomaterials, 7 companies have licensed technologies and 3 spin-off companies have formed. More than 200,000 patients are walking around with medical devices made from these polymers and many more are in the pipeline. The products highlighted below are used in the clinic.

Antimicrobial sleeve for the prevention of pacemaker infectionsA sleeve made of polymer mesh about the size of a silver dollar, designed to hold a pacemaker or an implantable defibrillator. The mesh has an antibiotic coating that dissolves after seven to ten days, dramatically reducing the risk of infection following implantation. This product was originally made by TyRx Pharma, a spin-off company founded by Dr. Kohn. It was acquired by Medtronic in 2015. http://www.tyrx.com/index.htm

Resorbable & X-ray visible coronary scaffoldA polymer scaffold, made of radio-opaque polymer is undergoing clinical trials in Germany and Brazil and is expected to become commercially available in 2017. REVA Medical licensed the technology from NJCBM. The high performance polymers have the structural properties to achieve the scaffold strength required to treat challenging lesions that are restricting blood flow to the heart. The unique visibility under standard angiography (i.e. X-ray) allows the physician to check the placement and expansion of the scaffold in the artery during the implant procedure. Polymers used in non-REVA scaffolds are invisible, and physicians must rely on small permanent markers to determine where those scaffolds are positioned. Once its acute job of opening up the artery to restore blood flow is complete, the scaffold resorbs (i.e. disappears) from the body over a period of time, restoring the natural movement and function of the artery.

Additionally, the polymer also serves as the drug-delivery coating on the stent, allowing for controlled release of the drug, to minimize scar tissue formation after the scaffold is implanted. This drug delivery at the site reduces the likelihood of restenosis, or re-narrowing of the artery, which can sometimes occur in the area of the scaffold implantation. http://revamedical.com/

Resorbable surgical mesh for hernia repairThis device is a drug-eluting implant mesh made of biodegradable polymer which reinforces damaged tissue for better regrowth. This strong, yet flexible polymer allows for precise placement and easy trimming for optimal sizing. This technology was developed at NJCBM and licensed to BARD Davol. http://www.davol.com/products

Armed Forces Institute of Regenerative Medicine (AFIRM) Rutgers - Cleveland Clinic ConsortiumThe Rutgers-Cleveland Clinic Consortium (RCCC) is part of the Armed Forces Institute of Regenerative Medicine I (AFIRM I), a multi-institutional, inter-disciplinary net-work working to develop advanced treatment options for our severely wounded servicemen and women. AFIRM is managed and funded through the US Army Medical Re-search and Materiel Command (MRMC); with additional funding from the US Navy, Office of Naval Research, the US Air Force, Office of the Surgeon General, the Na-tional Institutes of Health, the Veterans Administration, and local public and private matching funding.

AFIRM’s mission is to develop new products and thera-pies to treat severe injuries suffered by US service mem-bers in the current wars. The AFIRM teams, working in research laboratories and clinics across the country, are advancing biological therapies (including adult stem cells and growth factors), tissue and biomaterials engineering, and advanced transplantation methods. These new treat-ments will enable the body to repair, replace, restore and regenerate damaged tissues and organs.

The RCCC consisted of 25 research teams that developed promising biomaterials, cell-based and combined regenerative medicine technologies that will

PROGRAMS OF THE NEW JERSEY CENTER FOR BIOMATERIALS

someday become new commercial products to restore lost tissue and function. In an effort to advance the commercialization of many of these products, the RCCC forged collaborations with nearly 20 industrial partners. The planned therapies will not only be available to the wounded warriors, but also to civilian trauma and burn patients as well.

In addition to the cutting edge research and development programs, the RCCC-AFIRM manages five clinical trials, enabling therapies for some of the most difficult challenges military medicine faces in the care of severely injured warriors:

Scar Remediation using Autologous Fat Transfer (University of Florida, and United States Army Institute of Surgical Research)

Face Transplant for Extensive and Deep Injuries to the Face (Cleveland Clinic Foundation)

Novel Immunosuppression for Kidney Transplants (Tolera Therapeutics, Inc.)

Engineered Skin Substitutes for the Treatment of Deep Partial-and Full-Thickness Burn Wounds in Adult Patients (Lonza Walkersville, Inc.)

Ex Vivo Produced Oral Mucosa Equivalent to Treat Large Intra-Oral Defects (University of Michigan)

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Dr. Kohn briefs military clinicians

3-point bending test to evaluate the mechanical properties of a biodegradable nerve conduit

Nation’s first face transplant patient, Connie Culp (R) with Dr. Maria

Siemionow (L) and General James F. Amos (middle)

Rat growing a human ear

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Joint Warfighter Medical Research ProgramThe Joint Warfighter Medical Research Program (JWMRP) is a dynamic program that facilitates the maturation of previous congressionally funded research efforts that demonstrate the potential to close identified military medical capability gaps. By focusing on both early and advanced technology development, the JWMRP offers a pathway to transition products to military health care providers and the warfighter.

Rutgers, NJCBM Program for Advancing Regenerative Therapies (PART) is a seamless - but reduced - extension of the Rutgers Cleveland Clinic Consortium (RCCC) of the Armed Forces Institute of Regenerative Medicine (AFIRM I). The objective of PART is to maintain the mission-focused culture of synergy and collaboration that was developed under AFIRM I to produce rapid progress in regeneration/restoration therapies for peripheral nerve and burned skin.

Three of the most promising projects for solving key regenerative medicine challenges in AFIRM I transitioned into the PART with the named collaborators:

Developing a therapy to limit burn injury progression aligns with the Combat Casualty Care Program to provide integrated capabilities for far-forward medical care to reduce the mortality and morbidity associated with major battlefield wounds and injuries as well as the Clinical and Rehabilitative Medicine Research Program to reset the wounded warrior in terms of duty performance and quality of life by improving restoration of function. Such a therapy is being developed under the following project.

Investigational New Drug (IND) Filing for Intravenous cP12 and Pre-IND Studies of Intravenous and Topical cNP5 To Limit Burn Injury Progress (Neomatrix Therapeutics, Inc.)

JWMRP is a resource for the Department of Defense (DoD). JWMRP is managed by the Office of Congressionally Directed Medical Research Programs (CDMRP) and is funded through the DoD, via annual Congressional legislation known as the Defense Appropriations Act. The JWMRP complements the Defense Medical R&D Program (DMRDP) by facilitating the further development of promising medical solutions through the acquisition process.

PROGRAMS OF THE NEW JERSEY CENTER FOR BIOMATERIALS

Topical application of cP12-loaded collagen gel onto the burn 1 hour after injury

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Repair of Segmental Nerve Defects - Tissue Engineered Nerve Grafts (University of Pennsylvania)

A Theragnostic System Solution for Optimal Nerve Repair (Massachusetts Institute of Technology)

Topical Therapies to Inhibit Burn Injury Progression (NeoMatrix Therapeutics, Inc.)

sMEA (stretchable microelectrode array) and ground wire in contact with gastrocnemius

muscle to initiate muscle contraction

a.TyrPC nerve wraps fabricated for 5 cm nerve defect model in pigs, b. axonal stretch-growth in culture

a. b.a.

PROGRAMS OF THE NEW JERSEY CENTER FOR BIOMATERIALS

RESBIO - Integrated Technologies for Polymeric Biomaterials, Bioactive Scaffolds and Cell-Biomaterial InteractionsRESBIO is an NIH-funded national biomedical technology resource that fosters multi-disciplinary investigations and multi-institutional collaborations with the goal of integrating chemical, biological and materials research to advance the discovery of polymeric biomaterials for regenerative medicine, the delivery of biological agents, and the development of bioactive scaffolds and medical implants. The overarching aim is to supply biomedical researchers with the biomaterials, bioactive scaffolds and medical implants and tools for studying cell-biomaterial interactions in order to enable new medical therapies. RESBIO has been funded by the NIH since 2003 and is currently in its third five-year phase.

How you can work with RESBIO

COLLABORATION. RESBIO seeks academic collaborators who can extend its core technologies to more areas of biomedical research. This occurs when collaborative projects are in synergy with RESBIO’s core research capabilities. Selected projects receive collaborative resources from RESBIO but no direct financial support.

SERVICE. RESBIO’s established methods and tools can be available on a service basis to biomedical researchers - both academic and industrial. Here, validated procedures using RESBIO’s state-of-the-art equipment are performed for outside investigators.

TRAINING. Training in the core technologies is available on an individual basis for selected scientists. Periodic workshops, some in partnership with advanced equipment vendors or other NIH-funded resource programs are a major training opportunity. All training activities are open to academic and industrial scientists.

DISSEMINATION. Publication of peer-reviewed articles, presentations at diverse conferences, and a web presence all contribute to disseminating RESBIO’s research. The New Jersey Symposia on Biomaterials Science bring RESBIO research together with the world of clinical applications and commercialization.

RESBIO’s goals in Phase 3 (2013 - 2018)

1. Develop bioactive scaffolds to elicit a range of predictable and desirable cellular responses within the context of a specific application.

2. Develop a deeper understanding and the necessary tools to investigate the basic signaling mechanisms that guide the cellular response to specific scaffold properties.

3. Disseminate new methods and technologies developed by RESBIO to the biomedical community and initiate an industrial network for innovation.

RESBIO III 2013 - 2018

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Research Interests

Optimization of topical, transdermal & transmucosal drug delivery; development of novel skin permeation models & computational modeling.Design & evaluation of novel dermal penetration enhancers and retardants & their structure-activity relationships. Using enhancers for transdermal delivery of actives for the treatment of Alzheimer’s disease, dementia, multiple sclerosis and other CNS disorders.Design and testing of novel nanosphere and siRNA topical formulations for the treatment of acne and melanoma respectively.Visualization of drug transport pathways in skin using Raman, Fourier Transform Infra-Red spectroscopy, electron and confocal microscopy.Development of novel human tissue cultured skin equivalents for permeability testing.Computational approaches to predicting skin transport of drugs.Designing new approaches to dissolution testing of novel dosage forms.

The advantage of our ultradeformable liposomes is that they are small in size and are flexible enough to squeeze themselves between skin stratum corneum cells and penetrate deep into the skin layers. These UDLs have potential application in the treatment of melanoma.

2. We are designing novel approaches to treating acne by encapsulating drugs such as adapalene in tyrosine-derived nanospheres (carriers) placed in topically applied hydrogel formulations. The challenge is to have the drug release inside the hair shaft that has a highly lipophilic environment due to the sebum produced in this area. Other applications of the nanospheres include drug delivery to psoriatic skin as well as for delivery of lipophilic cosmetic and pharmaceutical actives to skin layers.

Tissue- engineered human skin equivalents on bioactive polymeric scaffolds. Histology H&E images of (a.) human cadaver skin, and (b.) human skin equivalents on bioactive polymeric scaffolds

PROGRAMS OF THE NEW JERSEY CENTER FOR BIOMATERIALS

Center for Dermal Research - CDR / Director: Dr. Bozena Michniak-Kohn Contact: michniak@dls.rutgers.edu

Our Vision is to be the premier dermatopharmaceutics research center in NJ; conducting studies on topical and transdermal compound delivery, skin biology and skin tissue engineering. The CDR provides quality educational opportunities for its members through technical workshops, seminar series, symposia and courses. The CDR offers pharmaceutical, personal care, cosmetic and other companies an opportunity to participate in diverse activities through formal membership.

1. We are interested in developing and formulating ultradeformable liposomal (UDL) systems that after topical application can permeate deep into the epidermis and dermis and effectively deliver their cargo (siRNA) to the resident cells.

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3. We are fabricating polymeric scaffolds via electrospinning to construct human skin equivalents. Electrospinning provides tunable scaffolds and allows the scaffolds to mimic extracellular matrix properties. These tissue engineered human skin equivalents can potentially be utilized for in vitro irritation testing of topically applied drug compounds and formulations as well as potentially for application as skin grafts for wound healing.

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FACULTY SPOTLIGHT

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Joachim Kohn, PhD, FBSEDirector, NJCBM and Board of Governors Professor , Rutgers UniversityJoachim Kohn is a leader in biomaterials science and widely known for the development of tyrosine-derived, resorbable polymers, one of which is now used in an FDA-approved medical device. Kohn’s current research efforts focus on the development of a new “discovery paradigm” for revolutionary biomaterials using combinatorial and computational methods to optimize the composition and properties of biomaterials for specific applications, particularly tissue engineering and drug delivery. As a first demonstration of the utility of this approach, Kohn led a team of scientists who discovered an optimized polymer for use in a fully degradable cardiovascular stent which has been tested in clinical trials in Germany and Brazil. Additional clinical trials are planned.Contact: Kohn@dls.rutgers.edu

Carmine Iovine, MS Assistant Research Professor, Rutgers UniversityCarmine Iovine was Global Group Vice President for Research and Development for the ICI Group and Corporate Vice President for R&D at National Starch & Chemical Corp. before joining the faculty of the Center. He is an expert in the management of large research groups and the implementation of industry-academia interactions. His research interests focus on the chemistry of natural and synthetic polymers, water-soluble polyelectrolytes, and in the application of these materials to delivery systems, hard tissue engineering; personal care for skin, hair and dental; coatings; adhesive and sealant applications. He also has considerable expertise in the use of high throughput workflow techniques for the discovery of unique formulated products. Current projects include biodegradable & resorbable immunosuppressant drug delivery device formulation and dental enamel erosion protective coatings development.Contact: Iovine@dls.rutgers.edu

Hilton Kaplan, MBBCh, FCSSA, PhDAssociate Director, NJCBM and Associate Research Professor, Rutgers UniversityHilton Kaplan is a Plastic, Reconstructive and Maxillofacial Surgeon, and a Biomedical Engineer. His research focuses on neurosciences (neural prosthetics and implantable man-machine interfaces), and tissue engineering (decellularized composite tissues for limb and face allotransplantation). Dr. Kaplan is Associate Director of the NJ Center for Biomaterials and a Research Associate Professor at Rutgers University; and an Adjunct Professor in Regulatory Science at the University of Southern California. Contact: kaplanh@dls.rutgers.edu

Yong Mao, PhDAssistant Research Professor, Rutgers UniversityYong Mao has broad research experience in molecular biology, cell biology, biochemistry and microbiology. Having focused her academic and industrial research in extracellular matrix biology, Dr. Mao brings her expertise in tissue engineering and regenerative medicine to her new role at NJCBM. Her main areas of interest are cell-bioscaffold interaction; scaffold supported tissue regeneration, stem cell technology and antimicrobial activity of biomaterials. Currently, she leads multiple industrial research collaborations and manages the NJCBM biology laboratory.Contact: maoy@dls.rutgers.edu

Antonio Merolli, MD, FBSEVisiting Research Scholar , New Jersey Center for BiomaterialsAntonio Merolli is a Clinical Editor of the Journal of Materials Science: Materials in Medicine, as well as an active member of the American Society for Peripheral Nerve (ASPN). He is the past treasurer of the European Society for Biomaterials (2001-2009) and Editor of the book “Biomaterials in Hand Surgery” (Springer). Dr. Merolli is a Visiting Research Fellow in Biomaterials Science and Engineering (FBSE) and has investigated in many fields of interest for the application of Biomaterials in Orthopedic Surgery, like Bio ceramics (Hydroxyapatite and Bioactive Glasses) and biodegradable/bioresorbable polymers. He has expertise in translational in-vivo models and histological analysis (particularly by TEM, SEM and BSEM). In the past years he has expanded his interest in nerve regeneration and is currently studying the role of artificial nerve-guides in regeneration and repair of peripheral nerve, brachial plexus and spinal cord lesions.Contact: antonio.merolli@gmail.com

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Bozena Michniak-Kohn, PhDDirector, Center for Dermal Research (CDR) & Laboratory for Drug Delivery (LDD)Professor, Ernest Mario College of Pharmacy, Rutgers UniversityBozena Michniak’s research group focuses on biological membrane drug transport and delivery, involving principally topical and transdermal drug delivery. The main interest is the enhancement of drug permeation using chemical and physical techniques (iontophoresis, microneedles) as well as novel carriers (nanospheres). She also works on the tissue engineering of a full-thickness human skin equivalent, based on the co-culture of fibroblasts and keratinocytes using collagen and novel polymer meshes as dermal matrices.Contact: michniak@dls.rutgers.edu

Sanjeeva Murthy, PhDAssociate Research Professor, Rutgers UniversitySanjeeva Murthy has a broad background in materials science, biophysics and engineering, which he uses to develop and mine structure-property relationships with the goals of tailoring polymers for biomedical applications and studying interactions between cells and substrates at multiple length scales. His expertise includes use of x-ray crystallography for characterization of polymer surfaces, thin films, and interfaces in order to study cell growth and adhesion.Contact: murthy@dls.rutgers.edu

Ophir Ortiz, PhDSponsored Research Coordinator, New Jersey Center for BiomaterialsAssistant Research Professor, Rutgers UniversityOphir Ortiz obtained a PhD in Engineering from the University of South Florida, followed by a NIH T32 Post Doctoral Fellowship at the New Jersey Center for Biomaterials. After academia, she went to the medical device industry, where she worked both in R&D as well as Biocompatibility within Quality and Regulatory Departments. This has provided her with a well-rounded perspective of the research and development process, from the beginning of an idea all the way to commercialization. Contact: ortizop@dls.rutgers.edu

Sangya S. Varma, M.Sc., PhDChief Operating Officer, New Jersey Center for Biomaterials Associate Research Professor, Rutgers University Sangya S. Varma is a scientist: an inventor, an innovator and an educator. She developed a novel imaging technology and converted it into FDA approved and CE marked medical devices during her career in industry. As the Director of Professional Science Masters Program she was key in developing Rutgers Master of Business and Science MBS Degree program. She manages all of the operations at NJCBM alongwith sponsored programs - federal and industry.Contact: sangya@rutgers.edu

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FACULTY SPOTLIGHT

EDUCATION AND

WORKFORCE DEVELOPMENT

INTERNATIONAL EXCHANGE

CUTTING EDGE RESEARCH

DEVELOPMENT

PUBLICATIONS AND PATENTS

LICENSE AGREEMENTS

SPIN-OFF COMPANIES

COLLABORATION

NJ CENTER FOR BIOMATERIALS AND MEDICAL DEVICES

Stanley S. Bergen, Jr., founding president of the University of Medicine and Dentistry of New Jersey, commits startup funding to the new center

1ST SYMPOSIUM OF BIOMATERIALS SCIENCE

The first of a series of pilot projects spanning research, scholarships, industrial collaborations and academic meetings. Rutgers and NJIT leaders join with Bergen to fund projects and administration

NJCBM FORMALLY FORMED

New Jersey Commission on Science and Technology awards $3.5M to support

formal establishment and operation of the New Jersey Center for Biomaterials

NIH - T32 TRAINING WITHOUT BORDERS

First major federal award kicks off postdoctoral training in biomaterials

science. Program is later renewed twice for a total of 15 years of funding

CEMBR CENTER FOR MILITARY BIOMATERIALS RESEARCH

First Department of Defense award enables feasibility demonstrations and planning for future consortium on regenerative medicine

NIH - P41 NATIONAL BIOMEDICAL TECHNOLOGY RESOURCE CENTER, RESBIO

NJCBM becomes first and only NJ center to receive this prestigious funding for

multidisciplinary and cross-institutional research on polymeric biomaterials

1991 1992 1997 2002 2003 2004

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A Rutgers alumnus who brought his experience as a worldwide manager at Johnson&Johnson to help NJCBM develop international education programs

Sal Romano Founding UMDNJ president Bergen presents NJCBM award to Moses, who licensed Kohn Lab patents for a startup that evolved into TYRX, now part of Medtronic

Arikha Moses, Stanley Bergen

EARLY SUPPORTERS OF THE NJCBM VISION HELPED TO LAUNCH AND NURTURE OUR

MULTI-FACETED RESEARCH CENTER

(1991-2004)

Steinberg, a Princeton biologist, influenced NJCBM’s multi-disciplinary research agenda

Ken Breslauer and Class of 1954

Scopelianos, Director of the 1990s-era J&J Biomaterials Center, receives the first NJCBM award from Bergen (L) and Kohn (R)

Seneca, Rutgers VP for academic affairs presents NJCBM award to Zeltinger, VP of scientific affairs at REVA Medical, another licensee of Kohn Lab technology

Joan Zeltinger, Joseph Seneca

Stanley Bergen, Angelo Scopelianos, Joachim Kohn

Malcolm Steinbergdeceased

Rutgers Class of 1954 alumni helped to fund NJCBM’s new Clean Room. Breslauer, Dean of Life Sciences, displays plaque at commemoration

ARMED FORCES INSTITUTE FOR REGENERATIVE MEDICINE

NJCBM leads the Rutgers-Cleveland Clinic Consortium of 30 academic institutions

and companies, supported by the US Army Medical Research and Materiel Command

10TH SYMPOSIUM

From Materials Design to Scaffolds to Tissue Regeneration

CENTER FOR DERMAL RESEARCH

Bozena Michniak, Rutgers Professor of Pharmaceutics, establishes CDR, with goal of becoming the premier dermatopharmaceutics research center in NJ and providing unique

educational opportunities

JOINT WARFIGHTER MEDICAL RESEARCH PROGRAM

US Army Medical Research continues to support promising therapies emerging

from the AFIRM program

14TH SYMPOSIUM

Today’s Challenges and Innovationsin Biomaterials Science

2008 2010 2011 2014 2016

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PROGRAMS OF THE NEW JERSEY CENTER FOR BIOMATERIALS

RUNEG - Rutgers University Neuro-Engineering GroupRUNEG is a consortium of 17 neuroengineering faculty that was created in March 2014 with the mission of facilitating translational research in the development of devices that enhance central and peripheral nerve regeneration, restoration of motor and sensory function, and transmission of neural signals by brain-computer interfaces. RUNEG was conceived and implemented by Joachim Kohn, Director of NJCBM and Board of Governors Professor of Chemistry, and is currently supported by an award from Chancellor Richard Edwards together with discretionary seed funds from NJCBM. While focused on biomaterials science and the engineering disciplines, RUNEG brings together researchers from neuroscience, chemical biology, imaging, stem-cell technology, nanotechnology, and computational modeling, as well as physicians. RUNEG fosters these collaborative and interdisciplinary research efforts to enhance understanding of the multidisciplinary field of neural engineering, devices, and cellular therapies to enable the translation of technologies from bench to bedside. The group partners actively with members of the biomedical device and pharmaceutical industries, to accelerate the transfer and commercialization of inventions and technologies into clinically useful products and therapies through a streamlined approach. An important objective of RUNEG is to provide cutting-edge training and education, in the form of seminars and annual workshops, delivered by both world-class investigators within RUNEG and invited leaders in these fields.

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Pioneer axons of rat femoral nerve regenerating through never guidance conduit (longitudinal section)

Fluorescent labeled neurons

MRI of rat limbs for muscle volume follow-up in vivo

RUNEG symposium

Spinal cord motor neurons of femoral nerve nucleus

(L=uninjured, R=post injury)Fluorescent marker validation of osmotic pump for delivering test drugs to nerve guidance conduit repair site

Cross-section of nerve for axon counting and g-ratio measurements

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NEUROSCIENCE INITIATIVES

The NJCBM has a world-class neurosciences thrust, working in cutting-edge areas of research and collaboration across both the central and peripheral nervous systems. We encourage interested scientists to reach out and participate by collaborating or potentially joining this very strong effort.

Peripheral Nerve Regeneration (Bioengineering Research Partnership)Peripheral nerve injuries require regeneration across gaps to their target muscles. The current standard of care is to use nerve autografts (nerves from elsewhere in the patient’s body), but this involves significant donor site morbidity, mismatched repairs, and increased costs. An alternative to autografts is nerve guidance conduits (NGCs), comprised of three components - a wall, filler, and bioactive molecules - in an infinite number of potential variations and combinations. We believe that the development of effective NGCs is especially beneficial for the unsolved problem of long nerve gaps and gaps across articulating joints.

Funded by the NIH’s National Institute of Neurological Disorders and Stroke, the Bioengineering Research Partnership collaboration combines three technologies

invented in three laboratories at Rutgers, toward translation of a device for repairing these large gaps, and specifically with appropriately directed motor-sensory pathways. Neurobiology, biomaterials and bioengineering researchers are conducting laboratory and preclinical studies to create a prototype off-the-shelf NGC for peripheral motor nerves, that enhances not only the rate of regeneration, but also the accuracy of restored motor pathways.

Decellularization & Recellularization of Nerves & Composite Musculoskeletal Tissues (Osteo Science Foundation)In traumatic craniofacial and musculoskeletal injuries, and massive burn scarring, quality of life is dependent on restoring form and function. Regeneration within the scarred soft tissues and large bony defects is highly dependent on robust vascular supply and sensory-motor reinnervation. This project aims to decellularize donor neurovascular bundles, with and without the muscle groups they supply, so that these tissues can then be reendothelialized and recellularized with recipient cells, to create autologous (host) tissues for transplantation.

This will provide off-the-shelf scaffolds that can readily be made into tissues that are considered “self, ” for reconstructing large avascular, asensate and/or paralyzed defects. By providing vascularized nerve grafts of required diameter and length, large peripheral nerve gaps can be repaired; engineered tissues can be innervated and vascularized; and blood supply and sensation can finally be returned to scarred or irradiated tissue beds; all without the risk of any rejection.

Braided kink-free nerve guidance conduit(top) Peripheral nerve

regeneration through conduit (bottom)

Rabbit femoral neurovascular bundle Rat quadriceps: after explantation, the aorta and vena cava are cannulated and mounted onto a 3D printed board, to allow unimpeded fluid flow during de/recellularization

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ORTHOPEDIC INITIATIVES

Alveolar bone and tooth scaffolds. In vitro and in vivo approaches will be used to define optimized scaffold formulations for human alveolar bone and tooth regeneration. Reference: : Courtesy of Dr. Pamela Yelick. Funding source:

AFIRM II, CF-04.

Craniofacial and long bone defectsAccording to the American Academy of Orthopaedic Surgeons, musculoskeletal conditions in the United States cost society hundreds of billions in medical care and lost productivity. Although orthopedic injuries in the civilian population are quite common, complex and extensive military combat-related orthopedic injuries (e.g., large gap defects) have increased the challenges of orthopedic treatment. Polymeric biomaterials have been successfully used in orthopedic applications, but are effective only as treatments for small bone defects (less than 3 cm). The team at the NJCBM aims to design, fabricate, and evaluate bioactive polymers to be used in polymer-based orthopedic devices that will speed healing of large bone defects (greater than 3 cm), while reducing both pain and medical costs. Funded by the Department of Defense’s Armed Forces

Institute of Regenerative Medicine I and II, these projects aim to develop scaffolds for repairing large gaps in the cranium and long bones. These projects bring together leading academic and military research laboratories and clinicians, teams that combine world-class expertise in materials science, polymer chemistry, engineering, and biology. The research objectives of these projects are to demonstrate safety and efficacy in animal bone defect models, with the ultimate goal of translating these results into clinical treatments for the military and civilian populations.

E1001(1k) scaffolds , which are based on Tyrosine-derived polycarbonates, were tested in a goat calvaria critical sized (20 mm) defect model. In the histology images above, four treatment groups are shown: (A) Predicate device (commercially available product composed of polymer and β-TCP); (B) E1001(1k) and dicalcium phosphate dihydrate, (DCPD); (C) E1001(1k) and β-TCP; (D) E1001(1k) and β-TCP plus 400 μg rhBMP-2. Histology specimen were stained with Stevenel’s Blue and counterstained with van Gieson’s picrofuchsin. With this staining combination, non-mineralized structures appear as various shades of blue, and bone appears as red. Bridging through the critical size defect occurred in the E1001(1k) plus DCPD treatment group without the addition of rhBMP-2.Funding source: AFIRM II, ER-10.

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Alveolar bone and tooth constructs In the United States, more than 70 million adults are potential candidates for dental implants. Approximately 5 million implants are placed each year, and resulting in one failure every four minutes. Implant failure is a major concern because re-implantations are increasingly difficult. Funded by the Department of Defense’s Armed Forces Institute of Regenerative Medicine II, this project aims to develop bioresorbable scaffolds that promote alveolar bone and tooth formation using autologous and/or allogeneic dental progenitor cell populations. The research team at the NJCBM is developing biphasic scaffolds that are able to regenerate tissue interfaces, such as the interface between bone and teeth. The biphasic scaffolds are fabricated as a single scaffold with two distinct polymer layers, one that supports the growth of one tissue type (e.g., bone), and the other that supports the growth of another tissue type (e.g., tooth). In this way, a scaffold with two well-integrated, yet distinct regions is obtained.

The zone of integration is well defined and discrete. The long-term objectives of this project are to demonstrate safety and efficacy in small and large animal models. This work is collaboration between Joachim Kohn’s laboratory at the NJCBM and Pamela Yelick’s laboratory at Tufts University.

Single-head FDM printer from Type A Machines

Pressure assisted solvent-cast printer from BioBots.

Making 3D Tissue Engineering Accessible to ALL!The 3D printing laboratory enables for the rapid creation of scaffolds composed of a wide variety of materials from soft hydrogels over polymer melts up to hard ceramics and metals.

Tissue engineering and controlled drug release require 3D scaffolds with well-defined external and internal structures. The main goal of our Lab3DP facility is to employ 3D printing technologies as a manufacturing process for development of regenerative tissue scaffolds and medical devices, to support ongoing research in the Center. We are focusing on the most commonly used and commercially available 3D printing technologies, including fused deposition modeling (FDM), solvent-based printing (including bioplotting) and inkjet printing.

3D PRINTING INITIATIVES

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Dual-head FDM printer from Monoprice

Purchase of the state-of-the-art EnvisionTec’s 3D Bioplotter System-Manufacturer series BIO-01-1000 marks a great milestone in Centers’ 25-year history by making tissue engineering accessible to all. This printer provides many new features which have enhanced our tissue engineering capabilities: built-in camera to enhance needle calibration and to ensure consistent prints, temperature controlled build platform and sensor ports, greater material variety and finely tuned environments for low tolerance scaffolding, five cartridges slots for more materials in a single print.

The 3D-Bioplotter system is a rapid prototyping tool for processing a great variety of biomaterials using Computer Aided Tissue Engineering from 3D CAD models and patient CT data to create a physical 3D scaffold with a designed outer form and an open inner structure.

3D Printed Scaffolds

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TRAINING AND WORK-FORCE INITIATIVES

T32 Training without Borders is a program that challenges postdoctoral researchers to work across a dispersed scientific community. The program delivers unique research experiences built around special combinations of expertise, and draws its faculty from six institutions. Each faculty member is a leading researcher in his or her own field. Many of them are currently collaborating, and all are eager to co-mentor new trainees in individualized research projects at the frontiers of regenerative medicine. The NIH has been funding this groundbreaking, geographically distributed training program under NJCBM’s leadership since 2003. Trainees in 2016 are pictured at right.

Postdoctoral Research Training / NIH T32 - Translational Research in Regenerative Medicine

The 14 mentors for this program are based at Rutgers University, Boston University, Princeton University, Massachusetts General Hospital/Harvard Medical School, Case Western Reserve University and Mayo College of Medicine.

The Training Community

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Emmanuel Ekwueme Renea Faulknor Matthew Kutys

Alexandra Pastino Omid Rahmanian

Arnold Caplan Christopher Chen Stanton Gerson Martin Grumet Joachim Kohn Bozena Michniak Prabhas Moghe Case Western Reserve Boston University Case Western Rutgers University Rutgers University Rutgers University Rutgers University University Reserve University

Harald Ott Jean Schwarzbauer Cathryn Sundback Joseph Vacanti Anthony Windebank Gary Wnek Michael Yaszemski MGH/Harvard Princeton University MGH/Harvard MGH/Harvard Mayo College Case Western Mayo Clinic Medical School Medical School Medical School of Medicine Reserve University

International Summer Exchange ProgramThe New Jersey Center for Biomaterials at Rutgers University hosts an annual international summer exchange program as part of the International College of Fellows - Biomaterials Science and Engineering (ICF-BSE). The purpose of the program is to create valuable training experiences in leading edge biomaterials research for advanced graduate students. These young scientists are drawn from the most prominent biomaterials research laboratories worldwide for a 3-month summer research experience. Unlike many traditional exchange programs, each international student will have a pre-arranged work plan, access to state-of-the-art equipment, and the mentorship of a senior faculty member to advance their research and form lasting collaborations.

As of 2016, the International Summer Exchange Program at NJCBM has hosted students from 13 countries: Singapore, France, Brazil, Australia, Ireland, India, Poland, China, Taiwan, Italy, Spain, Germany and the United Kingdom.Undergraduate Summer Internship ProgramEach year, the New Jersey Center for Biomaterials proudly hosts a select group of promising undergraduate students to participate in its Undergraduate Summer Internship Program. Like the international exchange program, talented students with an interest in biomaterials research, are matched with a faculty mentor for 12 weeks over the summer. The selected students conduct laboratory research on a pre-determined project and showcase their summer work in a student symposium at the end of the program. The goal of the program is to expose promising

undergraduate students to scientific research and the laboratory environment, while providing individualized mentoring and hands-on experience in an on-going research study. Many of the selected students get to continue their research over subsequent semesters at NJCBM. In 2016, the Center hosted eight promising undergraduates for summer research.

ARESTY Scholars train at NJCBMARESTY scholars gain real research experience under the mentorship of NJCBM faculty, culminating with a poster presentation. Most continue the research projects as ARESTY fellows.

Caroline Kohn, PhD student in Pharmacy at the University of Leipzig, Germany and Xue Qu, Associate Professor at the School of Materials Science and Engineering, East

China University of Science and Technology, China

TRAINING AND WORK-FORCE INITIATIVES

From left to right: Joachim Kohn, Director NJCBM, Katherine Kim, Max Reinisch, Peidong He, Anya Singh-Varma, Justin Sotolongo Anisha Mahat, Bleema Bachrach,

Matthew Richtmyer, Dr. Yulin Li (Visiting Scholar)

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Poster presentation by ARESTY scholars Tyler Hoffman & Anya Singh-Varma, 2016

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Polymer Design, Synthesis, Characterization & ProcessingOur operating facility includes laboratories for polymer development and synthesis, which also enables us to manufacture commercial-grade polymers at the scale needed to support planned pre-clinical trials and initial product prototyping.

A team of polymer chemists are able to synthesize innovative polymers including scale-up to commercial scale in the Center’s large scale synthesis facility. Polymer processing equipment includes the capability to create 3D printed scaffolds, electrospun fibermats, extruded and injection-molded objects, and large-scale fiber spinning for textile applications such as weaving and braiding. The NJCBM is currently assisting several companies with polymer scale-up and manufacturing problems, and develops innovative solutions for bioreactor coatings. The NJCBM maintains a controlled document system for quality assurance, develops manufacturing SOPs, and has a certified Class 10,000 Cleanroom (equivalent to ISO 7 based on ISO 14644-1).

Polymer Design and Synthesis. Parallel polymer synthesis was used to facilitate a combinatorial approach to biomaterials design and discovery. An automated synthesizer, Chemspeed Accelerator, prepared structurally related biomaterial libraries. Currently, the NJCBM offers several polymer libraries with optimized chemical compositions for licensing or for academic collaboration. Kilogram Scale Synthesis Laboratory facilitates the scale-up of polymeric biomaterials and the tyrosine-based monomers that are integral to our research. Capabilities include increasing the batch size of polymers for medical applications; melt and solution polymerization techniques; reaction vessels up to 22 liters. The Polymer Processing and Characterization Facility provides the technological and theoretical means to process polymeric biomaterials into desired sizes and shapes, and to gain a better understanding of the materials properties through spectroscopic, thermal, physical and mechanical characterization methods.

NJCBM CAPABILITIES

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Confocal Laser Scanning Microscopy (Zeiss LSM410)Confocal Multiphoton Fluorescence Microscopy (Leica TCS S2 AOBS)Contact angle measurementGel Permeation Chromatography (GPC)Hydrogenator (Synthesis/processing)Mechanical Tester with Environmental ChamberQuartz Crystal Microbalance with Dissipation (QSense)

Capillary Rheometer (Malvern Instruments)Evaporative Laser Light Scattering (HPLC ELLS)High Pressure Liquid Chromatography withIndustrial-scale Extruder (Alex James & assoc.)Melt Indexer (Tinius Olsen)Microextruder (Randcastle)Modulated Differential Scanning Calorimeter (MDSC)Thermal Gravimetric analyzer (TGA)

In contrast to thermal processing, which inevitably degrades the polymer, solvent based methods allow a large variety of polymers to be fabricated into scaffolds, implants and devices without any thermal degradation. NJCBM has the know-how and the equipment to fabricate scaffold by porogen leaching and phase-separation, as well as by electrospinning to create fiber mats from nanofibers. Both of these techniques rely on the abililty of the polymer to be dissolved in suitable solvent.

SHARED ACCESS: affiliated technical facilities at partnering departments, centers, and faculty laboratories extend the range of technical capabilities to fully enable the multidisciplinary efforts necessary for biomaterials research and development

Cell Laboratory HPLC Large Scale Extruder with draw frame

Some of the major instruments are:

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Cell Biology & Cell Culture, PrototypingThe New Jersey Center for Biomaterials (NJCBM) Cell Biology and Cell Culture Laboratory is equipped to support research in cell biology, cell culture and manipulation, cell-material interactions, nucleic acid and protein analysis. The laboratory is also associated with a microbiology facility, which supports culture and manipulation of bacteria and viruses.

The Cell Biology Facility provides extensive capability for in-vitro characterization of materials, cell culture experimentation and experimental design; assay development, equipment assistance and user training in cell culture technique and research, four laminar flow hoods, four incubators, inverted and reflected light microscopes, benchtop microcentrifuge, fluorescence and absorption plate readers, horizontal gel electrophoresis apparatus, 24-well PCR thermal cycler is available for DNA and RNA analysis, realtime thermal cycling system for DNA/RNA copy number determination, hybridization and allelic discrimination.

Stem cells (red) growing on 3D printed scaffold (green)

NJCBM CAPABILITIES

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The NJCBM has large tissue culture facilities and has developed its own human, full thickness skin model (derived from primary human dermal fibroblasts and keratinocytes). This skin model is being used to evaluate the delivery of drugs from transdermal drug delivery systems.

The NJCBM recently acquired Q-Sense Pro, the latest technology Quartz Crystal Microbalance with Dissipation (QCM-D) apparatus. This is a fully automated instrument for research as well as for large-scale analysis that can be used to perform real-time analysis of surface-molecule interactions by measuring in situ changes in mass with nanogram precision and thickness changes at nanometers scale. The data can be modeled to monitor the changes in viscosity, shear modulus and associated structural changes as the materials interact with

Planned to enhance the interdisciplinary programs of the Center, this is a unique facility within an educational institution. The clean room provides a controlled environment for the processing of biomaterials, or for other operations used in materials research and pre-clinical studies.

PROTOTYPING: Our Class 10,000 (EN/ISO-14644 Class 7 US Federal Standard 209) cleanroom allows us to emulate production facilities for our prototypes

NJCBM also has the equipment necessary for coating quartz sensor crystals with molecular monolayers and polymer coatings. Coated layers can be characterized using our large suite of equipment available and this currently includes: spin-Coater, goniometry, atomic force microscopy (AFM), scanning electron microscopy (SEM) X-ray photoemission microscopy (XPS).

NJCBM is the Q-Sense North American Center of Excellence and through this collaboration QCM-D training courses are held quarterly in our laboratories.

a solvent. The simultaneous measurement of both mass and structural properties gives a thorough understanding of molecular adsorption and interaction under a variety of experimental conditions. This allows us to better understand the interactions between the scaffolds and the proteins and cells that surround it upon implantation, facilitating the development of new and superior scaffold materials.

3D Printing and Tissue Engineering (see page 17)

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Founded in 1991, the New Jersey Center for Biomaterials has prided itself on improving patient care and public health through the development of new biomaterials. With ongoing industrial partnerships, the Center strives to bridge the gap between scientific innovation and commercialization. Many of the world’s leading biotechnology and pharmaceutical companies are headquartered in New Jersey, many of whom have established a productive collaborative relationship with the Center.

Everyday, more start-ups are formed and are eager to become a major factor within the ever-expanding industry. These local companies, as well as many across the nation and the globe, are a part of our integrated networks for biomedical innovation.

We are currently involved with a wide array of projects under service, materials transfer, and research agreements. We strive to deliver the highest quality research while providing the necessary confidentiality and protection of intellectual property rights, in addition to our utmost adherence to research integrity.

Our novel and patented biomaterials and biomedical technologies are key in the establishment of licensing agreements with several companies. Additionally, the Center is an integral part of Rutgers, The State University of New Jersey, allowing industrial scientists the opportunity for a high standard of consultation and access to the hands-on education a leading academic institution can provide. Our team includes of inventors, innovators, entrepreneurs, former senior executives, medical professionals and experienced research scientists. We welcome the industrial research community to join forces with us to develop the products of tomorrow and shape the future of health and personal care. Please contact Dr. Sangya S. Varma, COO, NJCBM, at sangya@rutgers.edu for all your inquiries.

INDUSTRY ENGAGEMENT

200,000+ patients with medical devices using our polymers 70 US Patents issued on novel biomaterials, 7 companies have licensed technologies, 3 spin-off companies

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By the numbers

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ACKNOWLEDGEMENT

Over the last 25 years NJCBM has had the privilege of working closely with many companies and those interactions aided our Center’s growth. We would like to express gratitude to ALL our industry partners, collaborators, and sponsors.

We would like to publicly acknowledge the following, with their permission. We extend our gratitude to those that support us but choose to remain confidential.

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COLLABORATORS / PARTNERS

SYMPOSIA/CONFERENCE SPONSORS/EXHIBITORS

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COMMUNITY OUTREACH

The New Jersey Center for Biomaterials is celebrating its 25th year of bringing together members of the biomaterials community to share and present their ideas. On October 24 and 25, 2016, the NJ Symposium on Biomaterials Science will mark the 14th time researchers and industry collaborators have gathered to discuss the newest innovations in biomaterials. What was initially a bi-annual gathering is now organized as an annual meeting to keep up with the dynamic landscape of biomaterials.

This event, held in New Jersey, is a premier regional meeting that has gained recognition for its broad scope, stimulating themes, and interdisciplinary attendance. The goal of the Symposium series is to exchange information and ideas across the full spectrum of scientists working in the biomaterials field, by focusing on research and development topics that represent the

most current promising directions for ultimate medical application. Renowned researchers from academia, industry, government and the clinical arena present their research and findings at focused and topical sessions. This level of focus and detail ensures that attendees find value in their participation. This year, for the first time, abstracts were accepted for oral and poster presentations.

The Center is also host to many different presentations and workshops. The Biomaterials Lecture Series,

Symposia, Training and Workshops

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graciously endowed by the Rutgers Class of 1954, is an ongoing program featuring talks by leaders in biomaterials science and related biomedical issues. Numerous training opportunities are offered to academic and industrial researchers in various disciplines such as: cell biology, cell culture, molecular biology, microbiology, biomedical engineering and biomaterials as well as general cleanroom operations and FDA regulations.

On Rutgers Day, members of the Center showcase their technologies and scientific advancement to thousands of people: visitors, prospective students, their families, and alums. The visitors learn about the different roles chemistry plays in life. The P2P: Polymers to Patients display showcases polymer samples in different forms and their intended or potential medical applications.Rutgers University is one of the most diverse universities in the United States. This diversity is reflected and celebrated at NJCBM.

Let us know how NJCBM can be of service to you. Contact: cbmfrontdesk@dls.rutgers.edu

NJCBM COLLABORATORS

Linking to potential partners worldwide has become standard operating procedure for NJCBM. While the re-search and training programs have extensive lists of formal collaborators, less formal connections are maintained through the International College of Fellows of the merged biomaterials societies of 10 nations/regions that span the globe.

INTERNATIONAL COLLABORATORS

OTHER COLLABORATORSAllegheny-Singer Research InstituteCleveland ClinicCooper HealthCommonwealth Scientific and Industrial Research Organisation (CSIRO), AustraliaMassachusetts General HospitalMayo ClinicNational Institutes of Health (NIH)National Institute of Standards & Technology (NIST)New Jersey Commission on Spinal Cord ResearchRutgers University Neuro-Engineering Group (RUNEG)

Nanyang Technological University, SINGAPORE

National University of Galway, IRELAND

University of Naples Federico II, ITALY

University of New South Wales, AUSTRALIA

University of Paris,FRANCE

West Pomeranian University of Technology,

POLAND

Rutgers finds its home in the Big 10, and NJCBM reflects that in its large number of academic collaborators in the Big Ten Academic Alliance (formerly the CIC). NJCBM also has partners at many universities near us and across the globe.

Boston UniversityCarnegie Mellon UniversityCase Western Reserve UniversityClemson University Massachusetts Institute of Technology Philadelphia UniversityStony Brook University

Dartmouth CollegeHarvard University Princeton UniversityUniversity of PennsylvaniaYale University

Tufts UniversityUniversity of AkronUniversity of ChicagoUniversity of CincinnatiUniversity of FloridaUniversity of WashingtonUniversity of VirginiaVanderbilt University

Rutgers UniversityUniversity of Illinois University of MarylandUniversity of MichiganUniversity of Minnesota

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The New Jersey Center for Biomaterialsat Rutgers, The State University of New Jersey

145 Bevier Road, Suite 101, Piscataway, New Jersey 08854 tel: 848. 445.4888 www.njbiomaterials.org

The New Jersey Center for Biomaterials at Rutgers, The State University of New Jersey is one of the Leading

Academic Research Groups to address the Challenges of Biomaterials Discovery and Optimization through a Rational Interdisciplinary Approach.

The Center’s Comprehensive Program is Built Around Five Major Strategic Goals:

Copyright © 2016 NJCBM. All Rights Reserved.

• Research Excellence •• Education & Workforce Development •

• Partnerships with Industry •• Advancement of New Technologies toward Commercialization •

• Fostering Entrepreneurship •