Now available – Two highly characterizedReference Standards for residual host cellDNA: CHO genomic DNA and E. coligenomic DNA with the following benefits:

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highly sensitive and specific residualgenomic DNA measurement methodoptional protein extraction procedure tominimize sample matrix effectsno kit requiredprimer and probe sequences providedflexibility in labeling oligonucleotides

Standards

NEWLY RELEASED: Residual Host Cell DNA

Call for comments on the new GeneralChapter <1042> Cell BankingThis chapter, which provides users withpractical guidelines and current best practicesregarding the clonal derivation, production,characterization and qualification, and resupplyof cell banks used for manufacturing biologicaldrug products, is now published in PF 44(6). The 90 day commenting period closes on March31, 2019.

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Share your comments on the followingGeneral Chapter revisions and help informstandards development by March 31, 2019:

<1043> Ancillary Materials for Cell, Gene,and Tissue-Engineered Products: Additionalsections have been added to address regulatoryconsiderations and the impact of ancillarymaterial quality on product quality. Otherrevisions include topics such as identificationand sourcing, risk management, and ancillarymaterials residual level assessment andremoval.

<1046> Cellular and Tissue-Based Products:This chapter includes an overview ofconsiderations for the development of cell-based advanced therapies and tissue-basedproducts. Revisions have been madethroughout the chapter such as changes to thechapter title, donor eligibility, potency, dose-defining assays, and administration to patients.

<1047> Gene Therapy Products: Revisions tothis chapter include removal of referencesto Pharmaceutical Compounding- SterilePreparations <797>, changes to the definition ofliposome, and updates to the FDA GuidanceDocuments list.

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Call for comments: Submit your feedback before March31, 2019

USP Education is now offering a hands-on bioassay laboratory-based course that focuses on USPGeneral Chapters <1030>, <1032>, <1033> and <1034> along with laboratory execution of bioassayprocedures. In this highly interactive course, participants will learn key concepts of in vitro bioassays,including use of relevant terminology, best practices, design, development, validation, post-validation,analysis, interpretation and reporting of results. It’s a great opportunity for those who wish to understandthe best practices for analysis and consistent interpretation of data obtained from method developmentand validation. Scientists also gain hands-on laboratory experience and learn about the application ofappropriate statistical tools for data analysis.

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Thursday, March 14, 2019 | 12:00 pm Eastern

The webinar will focus on challenges related to measurement of process and product related impuritieswith a case study to illustrate the principles. Development of specifications within a product life cycleframework will be included with considerations that are helpful at each step. Regulatory and compendialguidance will be identified so that participants are aware of relevant references. A significant portion of thewebinar will focus on challenges related to measurement of process and product related impurities with ahelpful case study to illustrate the principles.

The webinar will be led by Dr. Michael Verlander, a well-known expert in this field, who has successfullybrought many synthetic peptides through the development and approval process.

Register today

USP Education Course: Bioassay/Method Developments

USP-sponsored Webinar: Evolution of Specificationsand Analytical Methods During Synthetic Peptide DrugDevelopment

Education Opportunities

USP held their annual two day workshop on Therapeutic Peptides-Regulations, Standards and Quality onNovember 5-6, 2018. On the first day speakers from organizations such as- Eli Lilly, FDA, Polypeptide,MIT and Arecor covered topics pertaining to regulatory considerations, manufacturing and control strategyconsiderations, and analytical technology. On the second day speakers from Sanofi, USP, Hikma, NeonTherapeutics, Immatics and other organizations presented on bioassay topics. Topics included cell-basedassays in compendial standards, bioassay and a phase-appropriate control strategy for synthetictherapeutic peptide APIs, peptide physical stability, and development of personal cancer vaccine NEO-PV-01.

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Event highlights

Peptides Workshop

As part of USP’s focus on working withstakeholders in South Korea, USP conducted itsfirst Biologics User Forum in Seoul, SouthKorea on November 13th, 2018. The forum wasa half-day discussion on usage of USPstandards and resources in the area ofbiologics. Strategic Customer DevelopmentManager Mr. Ankush Sharma updated theattendees on USP’s analytical methods andGeneral Chapters for recombinant therapeutics,USP Monographs and Reference Standards inproteins, peptides and blood products andUSP’s future approach for standards for biologicproducts. Mr. Joseph Eaton, Senior StrategicCustomer Development Manager, presented anoverview of USP’s Monograph and ReferenceStandard development process. The forum wasattended by more than 60 participants frommore than 20 organizations.

Korea User Forum

The Protein and Peptide Therapeutics and Diagnostics Research and Quality Assurance InternationalWorkshop (PPTD) was held on October 10th, 2018 in Chengdu, China. PPTD was hosted by InternationalBureau of Weights and Measures, National Institute of Medicine and National Institutes for Food and DrugControl and covered three sessions: Drug Characterization, Research and QC for In Vitro Diagnostics,and Reference Standards & Regulation. The speakers came from domestic industry, academic andinternational organizations such as BIPM, JCTLM, USP, IFCC, NIST and NIBSC. Dr. Fouad Atouf, USPVice President, Science – Global Biologics gave a presentation entitled, “Reference Standards forPeptides and Proteins, Value Assignment and Best Practices” as part of the Drug characterization andQuality Assurance session. PPTD attracted over 700 attendees from all over the world.

PPTDS in China

Regulatory considerations for personalizedmedicines are often related to complexscientific and implementation challengesthat span the entire production anddistribution process. In our currentapproach for developing standards forbiologics—which includes personalizedtherapies—we are helping to meet some ofthese challenges by prioritizing thedevelopment of standards for rawmaterials, as well as performancestandards, which apply to classes ofbiologics rather than individual products.

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Blogs

New blog: "Role of Standards in PersonalizedMedicine"

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USP continues to lead the way in biologics with new Reference Standards, education opportunities and global outreach. Read all about our effortsto advance the field in this newsletter.

In this issue:– Details on the newly released Reference Standards for measurement of residual host cell DNA– Upcoming education opportunities– New blog: "Role of Standards in Personalized Medicine"– Highlights from past workshop and meetings

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