By some estimates, the pre-approval cost of drug development is a staggering $2.5 billion per drug and takes an average of ten years from discovery to reach market. For novel therapeutics, the highest risk is during clinical trial manufacturing development, and biologics are no different. However, biologics drug product manufacturers face some unique challenges because they are made from biological sources. Some of these challenges are batch-to-batch consistency, changing impurity profiles, and molecular instability.
Join us for a webinar to discuss:
- Early phase development of biologics formulation
- Biologics analytical development
- Manufacturing process development designed to minimize the risk of delays from Concept to Clinic®
A Q & A session led by our panel of biologics experts will follow at the conclusion of the presentation.