Performance and Raw Materials Standards
Our public health impact grows significantly as we enable and support the work of the greater health community. USP is committed to identifying opportunities to set standards for Biologics. Email firstname.lastname@example.org to provide your feedback and learn about collaborating with USP to develop raw materials and performance standards.
Collaborative Testing Opportunities
USP Biologics has long-standing relationships with organizations across the globe, maximizing our impact in standards setting.
- USP Biologics participates in harmonization of Biotechnology Chapters through the Pharmacopeial Discussion Group (PDG), formed with representatives of USP, the European Pharmacopoeia, and the Japanese Pharmacopoeia.
- European Directorate for the Quality of Medicines & Healthcare (EDQM)
- Health Canada: Biologics, Radiopharmaceuticals and Genetic Therapies
USP Biologics works with Health Canada under the Cooperative Research and Development Agreement (CRADA) between the two organizations. Health Canada staff also volunteer in our Expert Committees, and their labs participate in our reference standard collaborative testing.
- National Institute of Biologics (NIB), Government of India
USP-India Biologics staff participates in collaborative testing of reference standards developed by NIB. In addition, the USP Biologics staff train NIB scientists, hands on in the laboratory, as well as in USP Workshops and PE courses. The training partnership will soon include joint training sessions.
- Pharmaceuticals and Medical Devices Agency
- UK: National Institute for Biologics Standards and Contro
USP Biologics has an MOU with NIBSC governing the collaboration on reference standard production, reference standard co-development and collaborative testing. In addition, NIBSC staff volunteer on our Expert Committees.
- US Food and Drug Administration
US FDA staff participate as liaisons on our Expert Committees, and work with USP Biologics staff on standards development. Our work together is governed by a CRADA, and work together on the FDA/USP Substance Registration System (SRS).
- WHO: Immunization, Vaccines and Biologicals
USP Biologics staff sit as observers on the Expert Committee on Biological Standardization (ECBS) as well as perform collaborative studies for ECBS. In addition, our Expert Committees provide input to their guidance documents.