- Rebecca Potts, Ph.D., Assistant Science & Standards Liaison – Global Biologics, firstname.lastname@example.org
Interested in learning more about the work of this Expert Committee?
Past Meetings – Executive Summaries
- Sign up and read the latest edition of the Global Biologics e-Newsletter.
- Explore relevant workshops.
- Anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue monographs and reference standards
- Selected general chapters that pertain to the anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue monographs
Expert Committee Charge
The Biologics Monographs 3 – Complex Biologics Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: Anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue.
- Work with other Biologics Expert Committees, FDA and stakeholders
- to improve existing complex biologics monographs
- to develop new product monographs in the area of coagulation factors
- on standards for cellular therapeutics
Subgroups and Expert Panels
- Cell Therapy Topics Working Group
- Coagulation Factors Expert Panel (coming soon)
- Factor IX Working Group
- Factor VIIa Assay Subcommittee
- Joint Subcommittee (Reference Materials)