- Mark Skasko, Ph.D., Science & Standards Liaison, Global Biologics mark.skasko@USP.org
Interested in learning more about the work of this Expert Committee?
Past Meetings – Executive Summaries
- September 16–17, 2019
- November 1–2, 2018
- September 27–28, 2017
- November 29-30, 2016
- February 9-10, 2016
- Don’t miss other important workshops.
- Sign up and read the latest edition of the Global Biologics e-Newsletter.
- 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- Modernization of outdated monographs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)