Hemophilia is a severe disorder caused by insufficient clotting proteins. Deficiencies in two of these proteins, coagulation factors VIII or IX, are a common source of this disorder and administration of these proteins is widely used to treat forms of hemophilia. In the past, these proteins were derived from blood but today they are usually recombinantly produced and highly purified. Potency assays for coagulation factors are complex multicomponent bioassays with many elements to consider for successful implementation. Ensuring that potency of the factors produced by various manufacturing platforms is consistent and meets the needs of physicians and patients can be challenging. The USP Expert Panel on Coagulation Factors is developing a new informational general chapter intended to provide users with principles and practical guidance regarding the reagent selection, in-house standard development, and validation of potency assays for coagulation factor VIII and factor IX concentrates. This presentation will provide an overview of the draft general chapter and an opportunity for stakeholders to provide input prior to its publication in the Pharmacopeial Forum.
This “What’s New in Biologics?” webinar is fifth in a series that shares the knowledge and expertise from USP staff and global experts on topics that will shape the future of biologics.

Subject area:
Biologics

Objectives (If applicable):
n/a

Target Audience (If applicable):
Manufacturers of coagulation factors
Regulators of coagulation factors
Coagulation factor Assay reagent manufacturers
Coagulation factor testing laboratories