Join Alcami for a webinar on Tuesday, April 16, 2019 to learn more about early phase development of biologics.
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 early phase 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.