- Diane McCarthy, Ph.D., Senior Science & Standards Liaison, Global Biologics, email@example.com
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- Monographs and Reference Standards (RSs) for recombinant and naturally derived proteins, including therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts
- Selected general chapters that pertain to monographs for therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extract
- Modernization of outdated monographs
- Identification and development of new monographs and RSs
Expert Committee Charge
The Biologics Monographs 2 – Proteins Expert Committee is responsible for the development and revision of USP - NF monographs and their associated USP Reference Standards in the following therapeutic categories: Therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts.
- Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs and develop new protein product monographs and Reference Standards
- Conduct workshops relevant to areas of interest to the Expert Committee
Subgroups and Expert Panels
- Enzymes Expert Panel
- Fc Function Assays Expert Panel
- Interferon beta-1a Subcommittee
- Pegfilgrastim-Filgrastim Subcommittee
- Joint Subcommittee (Reference Materials)