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Challenges of Bioassay Development and Specification Assessment for Biosimilar Product

Organization:
United States Pharmacopeial Convention
NIIMBL Funded:
No
Type:
Professional Development / Training
Relevant Technologies:
Analytical Methods / Technologies
Delivery Modalities:
Online/E-Learning
Type of Enterprise:
Tier 1/Tier 2
Contact:
[email protected]
Location:
Middle Atlantic
Duration:
0-1 Week
Description:
The development of potency assay(s) for biosimilars is based on the understanding of the known mechanism(s) of action of the molecule. This requires the sponsor to establish a functional cell-based bioassay at an early stage of the product development…