The ISCT Commercialization Committee: 1 Year On€¦ · Working with ISCT Executive leadership, an...

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1 The ISCT Commercialization Committee: 1 Year On About a year ago we had the good fortune to connect with some very motivated members of ISCT with great commitment towards advancing translational cell therapy. Working with ISCT Executive leadership, an Industry Task Force (ITF) was created to assess reciprocal value between industry and ISCT, which then led to construction of an Industry Community network and revamping of the ISCT Commercialization Committee (CC). It seems just a short while ago that we stood in front of the ISCT 2010 Annual meeting delegates, on behalf of the ITF, and laid out a vision on how ISCT as an organization could achieve greater strategic alignment with its industry members. We all recognize that the future of cell therapy is completely dependent on successful late stage clinical development reflecting the unity of translational investigators, regulators, and industry. Recommendations and conclusions from the ITF included that a new Commercialization Committee be developed to: foster new ISCT relationships with therapeutic and stem cell societies foster educational workshops and forums to cross-educate and standardize global practices in cell therapy create industry subcommittees to address priority initiatives, with clear benchmarks and global implementation establish a framework for a greater industry community within ISCT – opening doors for industry to share the new vision for commercialization of cell therapy emphasizing the regenerative medicine space. A founding Commercialization Committee membership was chartered to construct tangible steps to move these principles forward. Strong support was received from ISCT Executive leadership, and actions consistent with the strategic vision of the society have been executed over the last year. As a credit to committee membership, consistent engagement and contributions to this program have validated these objectives and rewarded our efforts. Very importantly, this committee has fostered new relationships across geographies and an increased international visibility for ISCT and its strategic goals. KEY ACHIEVEMENTS MAY 2010 TO MAY 2011 1. Identified leadership roles for industry in the Organization including the Executive, Advisory, Regional and Scientific committees. 2. Raised the profile of industry as a key link in the ISCT global translational hub of regulatory policy makers and institutional stem cell centers through publications, press releases and interviews: Publications: A changing time: the International Society for Cellular Therapy embraces its industry members. Cytotherapy, 2010; 12: 853–856 The International Society for Cellular Therapy: evolving to meet the demands of the Regenerative Medicine Industry. Regen Med. 2011 Mar;6(2):163-6. Cell Therapies; Commercializing a New Class of Biopharmaceuticals. BPI Supplement March 2011 Press Releases: ‘’International Society for Cellular Therapy (ISCT) joins forces with Roche and Genzyme to launch Cell Therapy Industry Partnership August 2010 • International Society for Cellular Therapy (ISCT) Launches Inaugural Cell Therapy Commercial Development Focus Group on Peripheral Vascular Disease, January 2011 Contributing ISCT interviews for articles in Science and Nature Biotech 3. Provided global front row insight to drive key development decisions through the launch of: ISCT Commercial Development Focus group Series • In keeping with its commitment to connect industry, regulatory experts, therapeutic societies and translational centers to advance emerging cellular therapies, the CC launched its first commercial development focus group addressing cell therapies for Peripheral Vascular Disease (PVD) in January 2011and plans for future forums targeting cell therapies for Inflammatory Bowel disease (IBD), stroke and graft versus host disease (GVHD) by the year end. ISCT BMCOGS global roundtables. • Also launching this year is the BMCOGS subcommittee’s global roundtable series on Cell Therapy Business Models and Reimbursement and a related series of informational documents on current policy and challenges for reimbursement determination in the various international regions. The first roundtable addressing issues and implications for experimental reimbursement codes for cell therapy in the US is confirmed for Sept 14 2011 in partnership with NMDP.

Transcript of The ISCT Commercialization Committee: 1 Year On€¦ · Working with ISCT Executive leadership, an...

Page 1: The ISCT Commercialization Committee: 1 Year On€¦ · Working with ISCT Executive leadership, an Industry Task Force (ITF) was created to assess reciprocal value ... Best Poster

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The ISCT Commercialization Committee: 1 Year OnAbout a year ago we had the good fortune to connect with some very motivated members of ISCT with great commitment towards advancing translational cell therapy. Working with ISCT Executive leadership, an Industry Task Force (ITF) was created to assess reciprocal value between industry and ISCT, which then led to construction of an Industry Community network and revamping of the ISCT Commercialization Committee (CC).

It seems just a short while ago that we stood in front of the ISCT 2010 Annual meeting delegates, on behalf of the ITF, and laid out a vision on how ISCT as an organization could achieve greater strategic alignment with its industry members. We all recognize that the future of cell therapy is completely dependent on successful late stage clinical development reflecting the unity of translational investigators, regulators, and industry.

Recommendations and conclusions from the ITF included that a new Commercialization Committee be developed to:

• foster new ISCT relationships with therapeutic and stem cell societies • foster educational workshops and forums to cross-educate and standardize global practices in cell therapy • create industry subcommittees to address priority initiatives, with clear benchmarks and global implementation • establish a framework for a greater industry community within ISCT – opening doors for industry to share the new vision for commercialization of cell therapy emphasizing the regenerative medicine space.

A founding Commercialization Committee membership was chartered to construct tangible steps to move these principles forward. Strong support was received from ISCT Executive leadership, and actions consistent with the strategic vision of the society have been executed over the last year. As a credit to committee membership, consistent engagement and contributions to this program have validated these objectives and rewarded our efforts.

Very importantly, this committee has fostered new relationships across geographies and an increased international visibility for ISCT and its strategic goals.

Key AChIevemenTs mAy 2010 To mAy 20111. Identified leadership roles for industry in the organization including the executive, Advisory, Regional and scientific committees.

2. Raised the profile of industry as a key link in the IsCT global translational hub of regulatory policy makers and institutional stem cell centers through publications, press releases and interviews:

Publications: • A changing time: the International Society for Cellular Therapy embraces its industry members. Cytotherapy, 2010; 12: 853–856 • The International Society for Cellular Therapy: evolving to meet the demands of the Regenerative Medicine Industry. Regen Med. 2011 Mar;6(2):163-6. • Cell Therapies; Commercializing a New Class of Biopharmaceuticals. BPI Supplement March 2011 Press Releases: • ‘’International Society for Cellular Therapy (ISCT) joins forces with Roche and Genzyme to launch Cell Therapy Industry Partnership August 2010 • International Society for Cellular Therapy (ISCT) Launches Inaugural Cell Therapy Commercial Development Focus Group on Peripheral Vascular Disease, January 2011 Contributing ISCT interviews for articles in Science and Nature Biotech

3. Provided global front row insight to drive key development decisions through the launch of:

ISCT Commercial Development Focus group Series • In keeping with its commitment to connect industry, regulatory experts, therapeutic societies and translational centers to advance emerging cellular therapies, the CC launched its first commercial development focus group addressing cell therapies for Peripheral Vascular Disease (PVD) in January 2011and plans for future forums targeting cell therapies for Inflammatory Bowel disease (IBD), stroke and graft versus host disease (GVHD) by the year end. ISCT BMCOGS global roundtables. • Also launching this year is the BMCOGS subcommittee’s global roundtable series on Cell Therapy Business Models and Reimbursement and a related series of informational documents on current policy and challenges for reimbursement determination in the various international regions. The first roundtable addressing issues and implications for experimental reimbursement codes for cell therapy in the US is confirmed for Sept 14 2011 in partnership with NMDP.

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4. Developed industry relevant education on Cell Therapy Commercialization:

Strategies for Commercialization Track at the 2011 Annual meeting Process and Product Development webinar series: • Cell Therapy Bioprocessing February 8 2011 • Potency Testing March 9 2011 • Immunotherapuetics September 7 2011 • hESC Manufacturing November 9 2011

5. IsCT Cell Therapy Bioprocessing Tools and Reagents Database- a service for members and the community at large.

Launching in Rotterdam, this is a no-cost opportunity for companies producing the tools and reagents to upload and promote the availability and application of their products. For end users, it provides a central location for cell therapy bioprocessing tools and reagents for you to find and compare product options, AND to rate and comment on your experience with the product. This will give new users and the product companies valuable feedback.

6. Created a Cell Therapy Industry Community:

Where innovators, researchers and investors, service providers and customers have the opportunity to connect, share expertise and address the obstacles to commercialization as a group with common challenges and the common goal of getting therapies to patients. Dialogue is facilitated through project collaborations, online and with our in person networking events such as the one being hosted here in the De Dolen. This has already proven to be an effective driver for new ISCT membership.

so what’s in store for the next 12 months?

Check out the ISCT website where we have listed our goals for this year which promise more access to experts, expanded international activity in Asia, more industry education and resources and alliances with other key industry organizations. In addition look out for resources that provide guidance and help remove ambiguity in the area of Potency Testing for cell therapy products.

The priorities of the group are driven by our members so if you want to see a business issue critical to you addressed then we encourage you get involved.

We send our thanks to all the Commercialization Committee and sub-committee members who contributed to these great achievements and our Industry Community members, represented here by their logos.

We look forward to continued work with you and the ISCT leadership team over the next year as a collective motivated by the common goal of getting innovative cell therapies into clinics for patients.

Best wishes,

Robert Deans, PhD

Executive VP Regenerative Medicine, Athersys, IncChair, ISCT Commercialization Committee

Francesco Lanza, mD

Head - Section of Hematology and BMT Unit, Hospital of Cremona, ItalyCo-Chair, ISCT Commercialization Committee

Richard maziarz, mDMedical Director, Adult BMT ProgramOregon Health and Science University, USACo-Chair, ISCT Commercialization Committee

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Table of Contents

Letter from the Chair & Co-Chairs of the ISCT Commercialization Committee ...................... 1

Corporate Supporter Acknowledgement ............................................................................. 4

Corporate Symposia and Tutorial Program at a Glance ......................................................... 5

Exhibit Floorplan ................................................................................................................. 6

Corporate Directory ............................................................................................................ 8

Corporate Symposia and Tutorial Program ......................................................................... 21

Richard maziarz, mDMedical Director, Adult BMT ProgramOregon Health and Science University, USACo-Chair, ISCT Commercialization Committee

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Corporate Supporters

IsCT wIshes To ACKnowLeDge The FoLLowIng suPPoRTeRs:

Silver Level Supporters

Bronze Level Supporters

Global Regulatory Perspectives Workshop Supporters

Award Supporters

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Young InvestIgator award

Best Poster aBstract award

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Wednesday May 18, 2011Time Company Room Title

2:30pm – 4:30pm Willem Burger ZaalsysTemATIC eXCeLLenCesm

PoweRFuL PLATFoRms AnD FLeXIBLe soLuTIons ThAT enABLe youR woRK To FLow.

5:00pm – 7:00pm Willem Burger Zaal new DIReCTIons In CeLLuLAR TheRAPy

Thursday May 19, 2011Time Company Room Title

12:30pm – 1:.30pm Fortis Bank Zaal

BIoPReseRvATIon AnD sTABILITy ConsIDeRATIons FoR CeLLuLAR TheRAPIes – CLInICAL APPLICATIons oF hyPoTheRmosoL® AnD CRyosToR® As AnCILLARy oR eXCIPIenT ReAgenTs

12:30pm – 1:.30pm Jurriaanse Zaal suRFACe mATTeRs FoR CeLL CuLTuRe

Friday May 20, 2011Time Company Room Title

12:30pm – 1:.30pm Willem Burger ZaalsePAX 2 – The essenTIAL ChoICe FoR AuTomATeD PRoCessIng In CeLLuLAR TheRAPy

12:30pm – 1:.30pm Jurriaanse Zaal gmP CeLL TheRAPIes: The new ReALITy

Corporate Program At-a-Glance Please refer to page 21 for full descriptions

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Exhibit Floor Planwednesday may 18 7:00pm – 9:30pm

Thursday may 19 10:15am – 3:30pm

Friday may 20 10:00am – 3:30pm

saturday may 21 10:00am – 1:15pm

Exhibitor DirectoryBooth # Company/organization

1 STEMSOFT Software Inc.

2 STEMCELL Technologies, Inc.

3 Aseptic Technologies

4 MVE-Chart

5 Corline Systems AB

6 Modul-Bio SAS

7 ICCBBA

8 Thermo Scientific

9 ATMI Lifesciences

10 CellGenix GmbH

11 Extract Technology Ltd.

12 TAP Biosystems

13 Pall Medical

14 PharmaBio

15 Cell Cryogenics Ltd.

16, 17 GE Healthcare

18 Sartorius Stedim Biotech

19 Beckman Coulter Inc.

20 MAK-System

21 Lonza

22 Pepro Tech

23, 24 CaridianBCT

25 Sigma-Aldrich Chemie GmbH

26 MacoPharma

27 Recuperate Medical

28, 29 BioLife Solutions Inc.

30 Miltenyi Biotec GmbH

31 Biosafe SA

32, 33 SANYO E&E Europe BV

34, 35 Kaneka Corporation

36 JMS Co., Ltd.

37 Accuri Cytometers (Europe) Ltd.

38 OriGen Biomedical

39 Life Technologies

40 ThermoGenesis

41 BD Biosciences

42 BioSpherix, Ltd.

43 R&D Systems Europe Ltd.

44 Immudex

45 Consarctic GmbHTable Top Display 1 Corning Life Sciences Europe

Table Top Display 2 SONIDEL

Table Top Display 3 BioProcess International

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*ISCT Cellular Therapy Bioprocessing Tools and Reagents Database Kiosk

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• A central location for cell therapy bioprocessing tools and reagent users to find and compare product options.

• A user interface to rate, comment and provide user feedback on specific products.

• A no-cost opportunity for product companies to upload and promote the availability and application of their products.

THE ISCT CEll THErapy Bioprocessing Tools And reAgenTs dATABAse

Launching at iSct 2011 NEW

Read full product specifications

Read reviews from your colleagues

Search by cell type, product name or company.

Visit the ISCT booth in the exhibit hall for a LIVE demonstration!

visit www.celltherapysociety.org

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ACCuRI CyTomeTeRs (euRoPe) LTD. Booth Number: 37

Accuri C6 Flow Cytometer, CFlow® Software and Workstation PC supply all the capabilities of a full-featured flow cytometer at a fraction of the price of the market leading systems. The C6 system includes blue and red lasers, four colour detectors and both forward and side scatter detectors plus software that is so intuitive that you will typically be up and running within an hour of receiving your Accuri system.

AsePTIC TeChnoLogIes Booth Number: 3

Crystal® ready to fill aseptic fill finish solution in polymer closed vials, vials resisting to very low temperature < -80°C, equipment range from manual to very high speed.

The Crystal® Closed Vial Technology enables safer and easier operations as it eliminates exposure to contamination and particles.

ATmI LIFesCIenCes Booth Number: 9

ATMI LifeSciences is an acknowledged technology leader in the field of single-use bioprocess systems and consumables for the pharmaceutical and biopharmaceutical industries. Its innovative, market-leading portfolio of single-use disposable storage systems, mixers and bioreactors is driving bioprocess efficiency and delivering value for biopharmaceutical companies around the world.

For more information, please visit www.atmi-lifesciences.comatmI lifesciencesreugelstraat 2, 3320 hoegaarden, BelgiumPhone +32 16 768070 | Fax +32 16 [email protected]

BD BIosCIenCes Booth Number: 41

BD Biosciences, a segment of Becton, Dickinson and Company, is one of the world’s leading businesses focused on bringing innovative tools to life science researchers and clinicians. Principal product lines include flow cytometers and cell sorters, cell imaging systems, monoclonal antibodies and kits, reagent systems, tools to aid in drug discovery and growing tissue and cells, and diagnostic assays. BD Biosciences customers are involved in basic research, the discovery and development of drugs and vaccines, clinical trials, diagnostic testing, and disease management. This diverse customer base includes academic and government institutions, pharmaceutical and biotech companies, and clinical laboratories.

BeCKmAn CouLTeR, InC. Booth Number: 19

Beckman Coulter provides comprehensive system solutions for cellular therapy research. With a thorough analysis of customer workflows, we’re able to deliver optimized solutions that consider every aspect of the experimental design process through data analysis. We integrate a variety of high performance reagents, instrumentation and custom software to help you automate, standardize and simplify each step of your cellular analysis study. With Beckman Coulter, you get better performance with accurate and efficient results throughout the cell therapy research continuum.

BIoLIFe soLuTIons InC. Booth Number: 28, 29

BioLife Solutions develops, manufactures, and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company’s proprietary serum-free and protein-free HypoThermosol® and CryoStor® and generic BloodStor® platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy,

Corporate Directory

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tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife also offers custom biopreservation media formulation, fill, and finish services, contract research, and consulting services for optimizing biopreservation outcomes in regenerative medicine applications. For more information please visit www.biolifesolutions.com.

BIoPRoCess InTeRnATIonAL Table Top Display 3

BioProcess International is dedicated to serving as the strategic educational bridge to help move Cell Therapies from laboratory to commercial scale. BPI will continue to delve into the science, technology and business realities of regenerative medicine to ensure this promising new class of biopharmaceuticals can take advantage and learn from the hard-fought lessons learned by other industry segments.

Please stop by our table top and pick up a copy of BioProcess International’s March 2011 Supplement: Cellular Therapies – Commercializing a New Class of Biopharmaceuticals.to view this supplement online, please visit: www.bioprocessintl.com

BIosAFe sABooth Number: 31

Biosafe Group SA is an internationally active medical technology company with its roots in the Lake Geneva region in Switzerland. Since it was established in 1997, the company has grown to become the industry standard in adult stem cell processing, serving stem cell banks, hospitals and research institutes alike with innovative cell processing solutions and the Sepax technology. With subsidiaries in the US and Asia and almost 30 distribution partners worldwide, today over 500 Sepax systems have been installed and more than 700’000 procedures have been processed by Sepax. Biosafe sa is a us Fda registered establishment, Japan, mhlw approved as well as an Iso 9001: 200 and Iso 13485:2007 certified company, working under the european medical devices directive 93/42/eec annex.II.3.

BIosPheRIX, LTD.Booth Number: 42

BioSpherix will be exhibiting the Xvivo System, the world’s first and only point-of-care cGMP compliant cell and tissue

incubation and processing systems for cell therapy.

Suitable for any cell processing application: explants or implants; minimal or maximal manipulation; autologous or allogeneic cells; pre or post biorepository. Accommodates any cell process: large or small; simple or complex. Offers unlimited flexibility: physically fits in any clinic or hospital; easy to reconfigure; simple to move. Stop by BioSpherix booth #42 and discover how the cytocentric Xvivo System is the practical, economical, and superior alternative to bricks & mortar clean rooms.

CARIDIAnBCT Booth Number: 23, 24

A leading global provider of technology, products and services in automated blood collections, therapeutic apheresis and cell therapy systems, pathogen reduction technologies and whole blood processes—specializing in blood component collection, safety, component separation and therapeutic apheresis. CaridianBCT is dedicated to improving lives through our people, products and processes.

CeLL CRyogenICs LTD Booth Number: 15

Cell Cryogenics provides novel and leading-edge technology to improve the cryopreservation of cells and tissues. Our products improve the quality and viability of the resultant cells and ensure compliance with regulations for handling and processing of therapeutic products. We address the crucial aspects of: controlled rate freezing (new larger systems), ice nucleation control (new compound), cryoprotectant media and, handling and storage of therapeutic cells with closed system cryovials.

Providing products for evaluation so that our customers can make decisions based on their own data is a core approach of Cell Cryogenics; we are always happy to discuss your cryopreservation needs and help you find the best solution.

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CeLLgenIX gmBh Booth Number: 10

CellGenix GmbH is an innovative biopharmaceutical company headquartered in Freiburg, Germany. CellGenix develops, manufactures, and markets medical devices, tools and cGMP-grade and research grade cytokines, serum-free media, and kit systems for clinical ex vivo cell processing for the optimal cell culturing of:• Dendritic Cells• Hematopoietic Stem and Progenitor Cells• NK-Cells• T-Cells• Mesenchymal Stem Cells• Chondrocytes• ESC and iPS cells

Ancillary materials for clinical cell therapy applications require highest quality standards. CellGenix’s extensive experience has enabled the company to build up a strong portfolio of products in the field of GMP-compliant production of cell and protein therapeutics. Continuous interaction with various competent authorities assures compliance with highest quality standards in the fields of individual biopharmaceuticals and cell based medicinal products (i.e. various FDA Drug Master Files).• CellGro® GMP Cytokines • CellGro® Research Cytokines • CellGro® Serum-free Media • CellGro® Closed Kit Systems

CeLL TheRAPIes PTy, LTD. Not Exhibiting

Cell Therapies P/L provides a one-stop shop for organisations seeking a CMO with cGMP manufacturing and clinical trials expertise. We have worked with a wide range of cell types and are experienced in migrating research into the clinic. We work on a fees-for-service basis as we integrate our skills and experience with our client’s requirements.

FACT FILe

• Hands on experience with international regulatory guidelines

• Nine years experience in advanced cell therapy manufacturing

• >1,000 Products Processed Annually• Multiple International Collaborations

• Flexible Business Arrangements• Fully Integrated harvest, process & cryostorage cryo

capabilities• 24/7 Communications• Confidentiality Protocols• Five Clean Rooms• Advanced cell tracking including: PET, SPECT & PET/CT,

3T-MRIouR CAPABILITIes In AuToLogous & ALLogeneIC CeLL TyPes InCLuDe:• Chondrocytes Osteoarthritis• Dendritic Cells Myeloma, Melanoma, HepC, Lung,

Breast & Ovarian Cancer• Islets Diabetes• MAK Cells Ovarian Cancer• Master Cell Banking • Mononuclear Cells Osteoarthritis• MSC’s Bone Repair, Cardiac Regeneration• HPC-A Haematological Malignancies, Breast Cancer• Peptide Fill N/A• T-Cells AML, MM, MDS

contact: ray wood - managing director, cell therapies Pty ltdground Floor, 10 st andrews Place, east melBourne, vIc, 3002Ph: 61 (0) 3 9656 1615 | cell: 61 (0) 419 344 530email: [email protected]

ConsARCTIC gmBh Booth Number: 45

BIoFReeZe®, BIoTRACe®, BIoLog:

Design and installation of complete biobanks for cryopreservation/conservation of (stem) cells, tissues (IVF), transplants and environmental probes. Stating for reproducibility, traceability and safety according to current MDD requirements. Biological freezers – liquid nitrogen refrigerators – inventory-control racks with sample repository software – MMS network multitank management – vacuum insulated liquid nitrogen distribution lines – SMS remote alarm – Oxygen deficiency system, etc.. Including installation, commissioning, IQ/OQ, training.www.consarctic.de, [email protected]

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CoRLIne sysTems AB Booth Number: 5

Corline® is a Life Science company dedicated to enhancing the well-being of patients by providing solutions that improve our OEM customers’ clinical products.

Corline® supplies biocompatible and pro-healing solutions based on a unique and proprietary surface modification technology - CHS™. CHS™ is proven and supported by scientific reports for a multitude of applications in both medical devices and the developing field of regenerative medicine.

CHS™ can be applied to biological surfaces (single cells as well as more complex biological tissues) without compromising their viability, reducing inflammation reactions and promoting revascularization of cells and tissue after transplantation. CHS™ has been approved for clinical studies in Diabetes Type 1 and is in pre-clinical in-vivo studies for use with mesenchymal stem cells and liver cells, as well as for tissue engineering applications within soft tissue and cardiovascular repair.

Corline® offers a truly unique immobilized heparin coating technology for use in Regenerative Medicine.

emo BIomeDICIne Not Exhibiting

Taipei-based EMO Biomedicine Corporation (www.emobio.com) was founded to provide contract services bridging analytical technology and cell-based products for clinical application.

Since 2004, EMO has been providing comprehensive biological and non-biological analytical testing services to local and global pharmaceutical and biotech clients. The R&D department of EMO has obtained the accreditation certificates both from Taiwan FDA and Taiwan Accreditation Foundation.

In addition to Contract Research and Testing services, EMO has been expanding its service scope to cell-based products contract manufacturing, to support cellular therapy clients who lack GTP/GMP compliant facility and quality system in Taiwan since later of 2010.

eXTRACT TeChnoLogy LTD. Booth Number: 11

Extract Technology are a leading supplier of containment and aseptic systems for the pharmaceutical, healthcare, biotech and chemical markets.

Our products include: Aseptic Process Isolators, Rigid and Flexible Containment Isolators, Downflow Booths, Pack off Systems and Dispensing and Sampling Facilities.

With a head office and manufacturing facility in Huddersfield, UK, we have over 30 years’ experience in the design and manufacture of innovative, high-quality solutions. In recent years we have developed a range of isolators for aseptic processing applications.

With successful projects completed for major companies worldwide, our reputation is built on customer service as well as our high quality and cutting-edge products.

Extract Technology can supply full installation, commissioning, IQ/OQ validation, OEL testing and also have a well established spare parts and service department.

Extract first became ISO accredited nearly 20 years ago, with quality playing an important role throughout the whole of our business.

ge heALThCARe Booth Number: 16, 17

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. GE Healthcare consists of 6 primary business units: Diagnostic Imaging, Surgery, Clinical Systems, Life Sciences, Medical Diagnostics, and Integrated IT Solutions. For more information, visit www.gehealthcare.com.

GE Healthcare’s Life Sciences business delivers breakthroughs in drug discovery, biopharmaceutical manufacturing and the latest in cellular technologies, so scientists and specialists around the world discover new ways to predict, diagnose and treat disease earlier. The Life Sciences business also makes systems and equipment for the purification of biopharmaceuticals. For more information, visit www.gelifesciences.com.

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genZyme Not Exhibiting

Genzyme is a global, diversified health care products company with approximately 10,000 employees worldwide. With research, manufacturing, regulatory and commercial hubs located around the world, Genzyme makes over 20 major marketed products available to patients. Genzyme is a leader in the effort to develop and apply the most advance technologies in the life sciences and has products focused on rare inherited disorders, kidney disease, orthopaedics, cancer and transplant and immune diseases. In April, 2011, Genzyme became part of the sanofi-aventis Group and will remain sanofi-aventis’ global center for excellence in rare diseases.

hosPIRA Not Exhibiting

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™ through the right people and the right products. Through its products, Hospira helps improve the safety, cost and productivity of patient care.

As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Hospira is also a leading provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies for formulation development, filling and finishing of injectable pharmaceuticals. Its broad portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. hospira is headquartered north of chicago in lake Forest, Il., usa.

ICCBBA Booth Number: 7

ISBT 128 is the global standard for the identification, labeling, and information processing of cell, tissue, human blood, and

organ products across international borders and disparate health care systems. The standard has been designed and perfected over a period of almost two decades to ensure the highest levels of accuracy, safety, and efficiency for the benefit of donors, patients, and health care professionals around the world.

our website address is www.iccbba.org

ImmuDeX Booth Number: 44

Immudex develops and commercializes products for the quantitation, characterization, and generation of antigen-specific T-cell responses for life science research, in vitro diagnostics and vaccine development. Immudex has a number of Research Use Only (RUO) products on the market, two products under development for in vitro diagnostic use, as well as a vaccine candidate in development for one of the most deadly of human diseases.

Immudex’s products are based on our proprietary MHC Dextramer technology; immobilization of MHC molecules and other immunologically relevant molecules onto a dextran backbone. The higher valence of MHC Dextramers compared to conventional multimer reagents enables more efficient detection of antigen-specific T-cells, increased signal-to-noise ratio, and clear separation of T-cell populations left ambiguous by the earlier generation of multimer reagents.

Please visit us at www.immudex.com. Improvement of the human condition through immunotechnology is our goal. dextramer technology is our tool. we are Immudex.

Jms Co., LTD. Booth Number: 36

JMS Co., Ltd., one of major medical equipment manufacturers in Japan, is going to exhibit a new medical device named CELLAID and our in-house made P(LA/CL) polymer at ISCT 2011.

CELLAID is a new medical device for preparing human serum. It has a completely closed system that protects the prepared serum from microbial contamination, and helps to make the serum rich in growth factors quickly.

Poly (lactide-co-caprolactone) (P(LA/CL)) is a kind of biodegradable synthesized copolymer which have a wide range of mechanical and degradable properties by controlling the ratio of lactide(LA) and caprolactone(CL). Film, tubing and sponge made of polymer will be displayed as a candidate for scaffold material in regenerative medicine.

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KAneKA CoRPoRATIon Booth Number: 34, 35

Kaneka Corporation is a producer of chemical products including resins, pharmaceutical intermediaries, food supplements, synthetic fibres and fine chemicals. The Innovative Bone Marrow MSC Separation Device harvests mesenchymal stem cells (MSC) via a filter from bone marrow:

i) with a higher recovery ratio of MSCs in a reduced operation time (approx. 20 min.)

ii) in a closed system operation after injecting the bone marrow into the bag

iii) with a higher efficiency in separationWe are now developing the Automatic Culture System for adhesive cells (ex. MSCs). By adopting the closed disposable cell culture kit, the risk of contamination is minimally, reduced. The compact body is equipped with the automatic medium change function and the real-time/scheduled monitoring/saving functions for checking the state the cell culture.

LABs, InC. Not Exhibiting

At LABS, Inc. we are committed to helping our clients develop innovative cell based products and therapies for use in basic research, tissue engineering and regenerative medicine applications. We leverage our 30+ years of scientific testing expertise in the biological and transplant sciences with our dedication to delivering accurate, timely and reliable results. LABS Inc. is your ideal partner to move your idea from concept and development through scale-up and commercialization.

LIFe TeChnoLogIes Booth Number: 39

Life Technologies (NASDAQ: LIFE) was created by the combination of Invitrogen Corporation and Applied Biosystems Inc. in 2008 and is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries

and developments that make life even better. As a leading supplier of tools and reagents for the science community, Life Technologies is proud to be the leading provider of novel tools for stem cell research, providing more than 1,500 products used by scientists in basic research, screening and drug discovery, and therapeutic applications. Our new Cell Therapy Systems (CTS™) brand of products allows scientists to more efficiently transition their stem cell research into the clinic through easily accessible documentation, such as certificates of analysis and certificates of origin and the highest level of technical, regulatory and web-based support.

LonZA Booth Number: 21

For 30 years Lonza has been helping emerging and established pharmaceutical and biotech companies improve production processes, navigate the development and regulatory process, lower the cost of goods, and advance to market faster. Lonza offers world class technology platforms in the areas of GMP cell culture and viral-based therapeutic manufacturing, custom biotherapeutic culture media, a large selection of primary and stem cells and a full line of custom bioassays. Our extensive experience in cell therapy process optimization and scale-up innovation helps clients to safely and effectively advance their products through all phases of the commercial pipeline and maximize their return on investment. Our new Viral-based Therapeutics group provides viral vaccine manufacturing as well as viral vector mediated gene therapies for the treatment of infectious diseases, neurological disorders, cancer and cardiovascular diseases. From early development through commercial launch and mature market supply our staff can design, develop, and implement a manufacturing process that meets your autologous or allogeneic therapeutic applications. For more information, contact us at [email protected]

mACoPhARmA Booth Number: 26

As Transfusion medicine evolves towards new cell therapies, Macopharma has also started to diversify into biotherapies and has developed a wide range of products to assist its customers into the field of regenerative medicine.

Thus the Biotherapy range of products provides solutions for every step of the cellular therapy process from the collection

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of various stem cells, the culture and cryopreservation of stem cells, up to the treatment and the transplantation of cells or organs to patients:

• Collection: cord blood and other stem cell collection bags• Freezing: Various size of cryopreservation bags and

pot for stem cell, tissues or femoral head• Cell Culture: An innovative closed system to culture

in GMP adherent stem cell, and a growing range of defined media

• extra Corporeal Photochemotherapy (eCP) : a very flexible process to treat efficiently patients with our special illumination bags, 8 Mop and Illumination device

• Transplant: Solutions to optimise the organ collection and transplantation

mAK-sysTem Booth Number: 20

Since 1984, MAK-SYSTEM has been specialized in designing innovative software solutions that deliver superior functionality for Cellular Therapy units, Tissue Banks, Cord Blood Banks, Blood Banks and Blood Transfusion Services. Our software solutions are implemented in more than 54 countries including 24 nationwide implementations.

The software solution T.C.S. is a complete and dedicated solution for the management of all aspects of Tissue, Cord Blood and Stem Cells Processing, from collection to transplantation / infusion.meet us for a demo at booth 20.

mILTenyI BIoTeC gmBh Booth Number: 30

Miltenyi Biotec founded in 1989, is a diversified biotechnology group of companies with a business focus on cellular technologies. With approx. 1200 employees in 18 countries, Miltenyi Biotec develops, manufactures, and commercializes innovations for both research and clinical applications. The portfolio provides integrated solutions for all areas covering sample preparation, cell separation, cell culture, flow cytometry, and molecular analysis.

Miltenyi Biotec develops, manufactures, and sells worldwide more than 2250 products and services, including magnetic particles, instruments, reagents and separation columns for specific cell isolation, sterile solutions and special culture media, recombinant APIs, cell therapeutics, and biological adsorbers for blood/plasma treatment.

Miltenyi Bioprocess, the contract manufacturing division of Miltenyi Biotec, provides a full range of services for developing and manufacturing biopharmaceuticals, monoclonal antibodies, cell culture media, recombinant proteins, peptides, antigens and medical devices. Viscover™ Imaging Agents, for highly innovative preclinical imaging applications complete the product portfolio.

visit www.miltenyibiotec.com to learn more.

moDuL-BIo sAs Booth Number: 6

Modul-Bio’s products portfolio includes:

MBioLABEL®: traceability solutions for Life Sciences laboratories, allowing identification of biological samples for long term storage, from labeling to scanning.

MBioLIMS®: a flexible Laboratory Information Management System developed specifically for Cell Therapy and BioBank facilities.

mAIn FunCTIonALITIes:

Management of Bags, Tubes and Plates

Printing of ISBT128 labels for CT Products Management of CT Products Storage Full audit trail, 21 CFR Part11, GLP ICCBBA Licensed Vendor

mve-ChART Booth Number: 4

MVE-Chart introduces the energy-efficient MVE Variō™Series into our line of liquid and vapor stainless steel freezers. The innovative design allows the tank storage area to remain completely dry with 1/10 the operating costs when compared with the leading mechanical freezers (-80°C).

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We offer a complete range of stainless steel freezers with vial capacities ranging from 3,200 to 94,000. Our vapor units maintain -190 C at the top storage box and still achieve the longest holding times and lowest LN2 consumption of any comparable freezer on the market. MVE-Chart also features a complete line of aluminum storage units including vapor shippers and nitrogen handling equipment.

oRIgen BIomeDICAL Booth Number: 38

OriGen Biomedical manufactures a complete line of containers for cryopreservation, cell culture and cancer research. We make closed-system cell culture bags in both FEP and our new Evolve(tm) material for larger and adherent cell cultures. Our systems can be produced with any tube set you desire and employ current needless and sterile dock technologies. Our Cryostore EVA freezing bags and EVO overwraps are suitable for direct immersion in liquid nitrogen. All our products are CE-marked, and available in a variety of sterile packaging configurations. Our DMSO solutions are also CE-marked and available in syringes or vials. Our products are latex, animal and Phthalate free, and have been tested and validated by customers and regulatory agencies worldwide. Custom products, specialty kits, and bags of any size, can be designed and supplied to meet your specific needs.

PALL meDICAL Booth Number: 13

Pall develops and manufactures innovative tools to enable the translation of cell therapies from the laboratory to the clinic. Our customers rely on Pall’s expertise in filtration, device, and system design to solve their most challenging problems.

Pall’s new Celeris WB System enables the rapid enrichment of total nucleated cells for use in human cell therapy applications. This simple and efficient system can be used intra-operatively at the point of care or in the clinical laboratory.

Pall’s cord blood collection, processing, and freezing bags for the cryopreservation of cord blood and cellular components are the industry standard. Our CE marked DMSO/Dex

solution is available in convenient single use vials. To learn more about our tools for cell therapy, visit our website at www.pall.com/celltherapy.

PePRo TeCh Booth Number: 22

PeproTech was established in 1988 to provide life science research with the highest quality cytokine products at the most competitive prices. Today, PeproTech is a world leader in supplying high quality cytokine products including E. coli, insect, and mammalian cell-derived recombinant proteins, their monoclonal/polyclonal antibodies, ELISA development kits, and other cytokine-related reagents. Their recent developments include a range of animal-free recombinant proteins and serum-free media supplement kits.

As a manufacturer PeproTech provides the highest level of technical support and customer service. This enables pack sizes to range from microgram to milligram quantities, and a custom vialing service is available to provide maximum flexibility to all customers. PeproTech is constantly striving to better meet the needs of customers and therefore welcome any feedback.

PhARmABIoBooth Number: 14

As cell and tissue therapies become standard of care, there will be an increasing requirement for regional manufacturing and banking resources that are both locally and internationally cGMP compliant. PharmaBio is a new entrant that brings cGMP compliant manufacturing for human cells and tissue. Headquartered in Nagoya, Japan, PharmaBio is well situated to support local and international requirements for manufacturing on either a fees-for-service or shared risk basis.

PharmaBio brings an established consumable and consulting services business to its new offering of a dedicated, four-story cGMP facility with three clean rooms and the support infrastructure able to deliver compliant cell and tissue products. These resources include a viral testing services and an in-house QC laboratory.

In conjunction with Cell Therapies Pty Ltd of Melbourne, Australia, (www.celltherapies.com.au), PharmaBio will

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provide a complete manufacturing resource to organizations that require internationally compliant manufacturing for their clinical trials, standard-of-care therapies or early stage research. The combined skills and experience of PharmaBio and Cell Therapies can lower the risk and accelerate the translation of research from laboratory to clinic.

PharmaBio has established links to the Japanese medical research and clinical communities, including a capacity to offer advice on Japanese regulatory compliance through PRARD and collaboration with local Universities and research organisations.contact: miki Isogai PharmaBio corporation tel: +81-3-6380-7821 [email protected]

R&D sysTems euRoPe LTD Booth Number: 43

R&D Systems has over 20 year’s experience developing innovative, high quality research reagents. We offer over 17,000 products, developed, manufactured and controlled in our own laboratories.

Our products include:

• Recombinant Proteins – expressed and purified to the highest standards using a variety of different expression systems. By maintaining stringent production and purification standards, we provide our customers with quality proteins that give consistent, reliable results. Certificate of analyses, and detailed documentation available, as well as bulk quantities.

• Animal-free Proteins – manufactured in a controlled-access facility, used exclusively for the production, purification, and filling of animal-free proteins.

• Antibodies – for neutralisation, cell phenotyping, IHC, Western blot

• Flow Cytometry antibodies, reagents and buffers

• Multiplex Assays – Luminex assays, membrane arrays and microplate arrays

• Cell Isolation Kits and specialised culture media and supplements

• Stem Cell Kits – for expansion, differentiation and functional identification of stem cells

• ELISA and ELISpot kits and reagents

For more information go to www.rndsystems.com

ReCuPeRATe meDICAL Booth Number: 27

ouR mIssIon sTATemenT

To be a leading source making best in class solutions available to support the human body to heal through “tissue” regeneration.

Bring doctors, scientists and engineers together in a collaborative environment in order to optimize the way patients are treated.

ABouT us

Recuperate Medical is focused on regenerative medicine and supplying human cell based technology products that support natural recovery. The products should increase surgeon’s influence on patient recovery process and help to improve patient outcome. We’re based in the Netherlands with representations throughout Europe.

guIDIng PRInCIPLes

The following principles guide us through our day-to-day activities ensuring our objectives are recognized and be maintained:• Make the best internal developed or external procured

technology available• Through education a/o clinical study introduce and

market high quality consumables to the regenerative medicine marketplace

• Promote, support acceptance of - regenerative medicine - knowledge, as a pivotal tool for modern medical therapy

• Embrace, support, and operate in a diverse multi-cultural work environment

• Ensure every action of the company meets or exceed our standards

• Adhere and work along internationally prescribed ethics in clinical practice

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sAnyo e&e euRoPe Bv Booth Number: 32, 33

nijverheidsweg 120, nl-4749 aZ etten-leur, Po Box 494, nl-4870 al etten-leur, the netherlands.tel: +31 (0)76 5433833; Fax: +31 (0)76 5413732; e-mail: [email protected];webpage: www.eu.sanyo.com/biomedical

SANYO Electric Co. Ltd. is a multibillion dollar global corporation developing advanced technologies and unique products for environmental, energy and lifestyle applications. SANYO E&E Europe BV is a Biomedical division dedicated to life science solutions based around user-driven innovations, such as dual-cooling freezers to ensure sample security. Headquartered in the Netherlands, SANYO E&E Europe BV has sales and service organisations in the UK, France and the Netherlands and manages sales, marketing, logistics and technical service for SANYO laboratory products throughout Europe.

SANYO Biomedical products include an array of laboratory equipment featuring industry-leading technology, controls, construction and performance. Product lines include V.I.P. ultra-low temperature freezers, cryogenic freezers, pharmaceutical and medical refrigerators, cell culture incubators, plant growth chambers, and portable autoclaves.

sARToRIus sTeDIm BIoTeCh Booth Number: 18

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry.

Its integrated solutions covering fermentation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions”.

sIgmA-ALDRICh ChemIe gmBh Booth Number: 25

Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. We have customers in life science companies, university and government institutions, hospitals and in industry. Sigma-Aldrich operates in 40 countries and has over 7,600 employees providing excellent service worldwide.

sonIDeLTable Top Display 2

SONIDEL is a supplier and developer of devices and accessories for the purposes of gene transfer. In particular we are active at an R&D level in the area of ultrasound-mediated gene transfer and have developed the SP100 Complete Sonoporation Solution and range of optimised microbubbles for sonoporation applications. We distribute the nePA21 Universal Electroporator, which is designed for in vivo and in vitro applications and which also includes a novel 2-Step output-pulse capability and a Polarity Exchanger for enhanced transfection efficiency.

sTemCeLL TeChnoLogIes, InC. Booth Number: 2

STEMCELL Technologies Inc. is a leader in the development of specialty cell culture media, cell separation products and ancillary reagents for the cell therapy market. Driven by science and a passion for quality, STEMCELL manufactures over 900 products for more than 70 countries worldwide.

STEMCELL Technologies offers a variety of solutions for the fields of banking and regenerative medicine. This includes StemSpanTM, a performance leader in maintenance and

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expansion of hematopoietic progenitors, MethoCultTM, the gold standard methylcellulose-based medium for detection of hematopoietic progenitors in the colony-forming cell (CFC) assay, and the recently launched STEMvisionTM, an automated instrument and computer system designed specifically for imaging and scoring colonies in the CFC assay. To learn more about these and other solutions offered by STEMCELL Technologies

sTemsoFT soFTwARe InC. Booth Number: 1

StemLab™ is the only complete laboratory manufacturing software solution developed exclusively for cellular therapy and cord blood banking. Designed by STEMSOFT Software Inc, StemLab™ is built to ensure quality and regulatory compliance standards are met by establishing procedural protocols, monitoring manufacturing processes, providing ISBT 128 identifiers, and documenting lot-to-lot traceability. Streamline your workflow by interfacing StemLab™ with your existing software systems and automated devices to eliminate duplicate data entry and ensure complete data integrity. For further information or to schedule your free demonstration on stemlab visit: http://www.stemsoft.com/Products/stemlab/solutions.asp or contact stemsoFt at 1-800-671-3234 or [email protected]

TAP BIosysTems Booth Number: 12

TAP Biosystems (formerly The Automation Partnership) provides advanced innovative automation systems and services for life science research, development and production.

TAP Biosystems focuses primarily on bioprocessing, cell therapies, cell-based testing / screening, discovery research, tissue engineering and sample management applications.

TheRmogenesIs Booth Number: 40

ThermoGenesis Corp., the market leader in stem cell processing and cryopreservation solutions, will showcase:

• The Res-QTM60 BMC enables you to process bone marrow quickly in a sterile environment for any point-of-care application with high MNC recoveries crucial to clinical success.

• The AXP™ AutoXpress™ Platform of products defines a new processing standard for concentrating stem cells from cord blood or bone marrow samples in a fully closed sterile system. It offers superior MNC recoveries and labor savings.

• The BioArchive® System- state of the art robotic cryopreservation system. Includes integrated control rate freezing and comprehensive data & sample management system.

PRoDuCTs InCLuDe:

• The AutoXpress™ - designed for processing cord blood

• The MarrowXpress™ - designed for processing bone marrow aspirate

TheRmo sCIenTIFICBooth Number: 8

Demand Thermo Scientific products whenever you need to go farther, analyze more and move science forward. The Thermo Scientific portfolio encompasses a broad array of high-quality instruments, reagents, laboratory consumables, equipment, and services. Our products are designed to help you run your laboratory at peak performance, from start to finish. See the entire Thermo Scientific line up at www.thermoscientific.com

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Experience the beauty of controlled growth.

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In your lab, quality correlates with reproducibility. With Thermo Scientific

Nunc cell culture products, you can count on the lot-to-lot predictability

you need to produce consistent results.

Reliability: All products are extensively tested and certified

Capability: Unique Nunclon® treated surfaces are preferred by

researchers

Scalability: Rely on quality even as you scale your work

Given the importance of your efforts and the depth of your commitment,

it only makes sense to reach for the best when it comes to your culture ware.

After all, control is a beautiful thing.

Visit www.thermoscientific.com/cellgrowth to learn more and to request

samples.

Visit us in Stand #8

Join our tutorial;

Surface Matters for Cell CultureWhen: 19-May @ 12:30

Where: Jurriaanse Zaal

ISCT Lavendar Fields.indd 1 4/27/11 3:52 PM

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bioreprogramming

Sigma, CompoZr, MISSION and Prestige Antibodies are registered trademarks of Sigma-Aldrich and its affiliate Sigma-Aldrich Biotechnology, L.P. Stemgent is a registered trademark of Stemgent, Inc.

Biopotential.Unlock extraordinary potential with stem cell technologies from Sigma®.

Stem cell biology offers astonishing research potential; Sigma® Life Science has the innovations you need to discover the promise it holds. Access a world of RNAi with the MISSION® RNAi Library, efficiently edit genes of interest using advanced CompoZr® ZFN technology, and characterize your stem cells with our Prestige Antibodies®, powered by Atlas Antibodies. The applications are endless—and so are the possibilities.

wherebiobegins.com/bioreprogramming

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Symposia and Tutorial Program

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sysTemATIC eXCeLLenCesm PoweRFuL PLATFoRms AnD FLeXIBLe soLuTIons ThAT enABLe youR woRK To FLow.

2:30pm – 4:30pmWillem Burger Zaal

2:30PM-2:35PM Noel Warner, PhD welcome and introductions

2:35PM-3:10PM Matthias Edinger, MDIsolation and expansion of human CD4+CD25+FoXP3+ Regulatory T Cells for Clinical Trials

3:10 PM-3:45PM James Brooks, PhDA serum-Free human Bone marrow mesenchymal stem Cell expansion system with growth Performance exceeding serum while maintaining multipotency and Immunophenotyping

3:45PM-4:20PM Shelly Heimfeld, PhDeffect of PBsC and Bm graft Composition on gvhD, Relapse and survival after Allogeneic Transplantation

4:20PM-4:30PM Paul Falkenstein, PhD BD Commitment to Cell Therapy enablement Closing Remarks

new DIReCTIons In CeLLuLAR TheRAPy

5:00pm – 7:00pmWillem Burger Zaal

AGENDA

Chair: Fred Falkenburg, Leiden University Medical Center, The Netherlands

5:00 p.m. Reducing alloreactivity by in vitro depletion of naive T cells Wolfgang Herr, University of Mainz, Germany

5:25 p.m. The curative potential of of γδT cells after allogeneic stem cell transplantationJuergen Kuball, University Medical Center Utrecht, The Netherlands

5:50 p.m. Coordinated isolation of CD8+ and CD4+ T cells recognizing Cmv pp65, Cmv Ie-1, or hAdv hexon protein for highly specific adoptive immunotherapyPauline Meij, Leiden University Medical Center, The Netherlands

6:15 p.m. Towards clinical-scale enrichment of mesenchymal stromal cells for orthopedic applicationsDennis McGonagle, University of Leeds, UK

6:40 p.m. Discussion

7:00 p.m. end

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BIoPReseRvATIon AnD sTABILITy ConsIDeRATIons FoR CeLLuLAR TheRAPIes – CLInICAL APPLICATIons oF hyPoTheRmosoL® AnD CRyosToR® As AnCILLARy oR eXCIPIenT ReAgenTs

12:30pm – 1:30pmFortis Bank Zaal

Speaker: Aby J. Mathew, PhD, Senior Vice President and Chief Technology Officer

Cellular therapies and regenerative medicine utilize cell and tissue products sourced from blood, bone marrow, and various tissues. The clinical and commercial success of these products is potentially impacted by stability limitations, which include transport of the source material and biopreservation of the final cell or tissue product (either frozen or non-frozen). Join us for an updated discussion of the critical role and impact of biopreservation economics in the development and commercialization of regenerative medicine products. Topics include best practices in optimizing biopreservation workflow, including transportation and storage of source material and final dose, intermediate manufacturing process hold steps, and evaluation, selection, and validation of ancillary and excipient reagents. Comparative yield optimization and stability extension data will be presented. Case studies of clinical applications in a broad range of cellular therapies utilizing HypoThermosol® for non-frozen products and CryoStor® for cryopreserved products will be discussed.

Biopreservation and Stability Considerations for Cellular Therapies – Clinical applications of HypoThermosol® and CryoStor® as ancillary or excipient reagents

suRFACe mATTeRs FoR CeLL CuLTuRe

12:30pm – 1:30pmJurriaanse Zaal

Speaker: Thomas Stelzer

This presentation will cover cell culture surface modifications on Thermo Scientific Nunc products, including energy treatment, ECM coating and surface graft.

Although in reality, it is difficult to accurately predict which surface chemistry would produce the best result for cell culture, Thermo Fisher Scientific works closely with the customer in designing and providing a variety of surfaces suitable for different types of cell culture.

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sePAX 2 – The essenTIAL ChoICe FoR AuTomATeD PRoCessIng In CeLLuLAR TheRAPy

12:30pm – 1:30pmWillem Burger Zaal

The Biosafe Group is honoured to have 2 renowned experts presenting some of the leading advances in the field of cellular therapy.

Firstly, you will hear an overview of the use of the Sepax 2, our versatile new platform for cell processing, presented by the super-user Mr. Lutz Koerschgen from the Jose Carreras Cord Blood Bank in Düsseldorf, Germany. Mr. Koerschgen is a scientific partner who actively contributed during the development phase of this advanced technology.

Subsequently, Dr. MD Marcus Egermann from the clinic for orthopaedics and trauma surgery in Heidelberg, Germany, will share his extensive knowledge of using the Sepax 2 for bone marrow concentration in various orthopaedic applications.

gmP CeLL TheRAPIes: The new ReALITy

12:30pm – 1:30pmJurriaanse Zaal

CellGenix and Afc are honored to be hosting two of the leading innovators in the industry: Dr Don Healey and Dr. Jan Spanholtz

Dr. Healey will discuss the challenges in autologous cell therapy from a manufacturing perspective. His talk will highlight the development of processes inherent in the scale up from institutional early phase clinical treatment of patients and the local collection and processing of cells as the process evolves into elements of compliance for moving to an external multi-center GMP environment. The challenges involve scale up process development, working with third party organizations, GMP reagents, closed system manufacturing, timely shipping of cellular products, controls, and more. The hurdles and bottlenecks described above will be reviewed in the context of Tovaxin, an autologous T-cell therapy for the treatment of Multiple Sclerosis.

Dr. Spanholtz will discuss the process of clinical grade generation of NK cells from Umbilical Cord Blood progenitor cells for immunotherapy using a closed system cell culture process. His talk will discuss the issues, development of protocols, and conditions required to facilitate clinical studies for the ex-vivo expansion of large numbers of cells in closed systems. He will also describe the dose of cells, washing procedure, and GMP reagents involved in the process without changing cell phenotype and cytotoxic activity for a successful phase 1 clinical study.

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