USP Biologics Newsletter
Stay up-to-date with USP's Biologics newsletter on the latest announcements and quickly access new guidelines, webinars and other valuable resources. Covered topics include the latest information on the development, approval and release of new standards for biologics and more.
Publications
- Survey of peptide quantification methods and comparison of their reproducibility: A case study using oxytocin *NEW*
- Quantitative Analysis of Impurities in Unfractionated Heparin of Bovine Origin *NEW*
- Recap of USP's 8th Annual Bioassay Workshop (Cell and Gene)
- Quality: A Standard Expectation
- USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics
- The BioPhorum and USP collaborative journey to new standards (BioPhorum)
- US Pharmacopeia Standards for Cell and Gene Therapy
- Survey of peptide quantification methods and comparison of their reproducibility: A case study using oxytocin
- USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics
- Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods
- Separation of 15 Underivatized Saccharide and Sialic Acid USP Standards
- Higher Order Structure of Proteins in Biopharmaceutical Development
- Managing Risk for Biomanufacturing Raw Materials
Blogs
- Quality standards for efficiency in drug development and manufacturing *NEW*
- USP Proposes Revision to Clarify Applicability of Standards to Transition Biologics
- Strengthening Biotherapeutic Innovations through Emerging Analytical Tools
- Antibiotics manufacturing components can trigger adverse reactions. Standards help restore quality and trust.
- A new generation of tools and standards for biologic medicine quality
- The Role of Standards in Personalized Medicine
- Rapid Microbial Methods: The Need for Speed in Cell and Gene Therapies
- Solutions to help ensure biopharmaceutical quality
News
USP Comments to FDA Biologics Guidelines
- USP Comments on FDA's Proposed Rule, "Designation of Official Names and Proper Names for Certain Biological Products" (Nov. 12, 2015)
- USP Comments on the INN BQ Proposal (Sept. 15, 2014)
- USP comments to FDA regarding “Draft Guidance for Industry, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product” (“Draft Guidance”), 79 Fed. Reg. 27622 (May 14, 2014); Docket No. FDA-2014-D-0234 (July 24, 2014)
- USP’s comments to FDA regarding Approval Pathway for Biosimilar and Interchangeable Biological Products (21–Dec–2010)