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ON-DEMAND WEBINAR: Extractables & Leachables
Requirements from regulatory agencies have become increasingly rigorous with regards to the detection, identification, and quantitation of...
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:
A Q & A session led by our panel of biologics experts will follow at the conclusion of the presentation.
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Requirements from regulatory agencies have become increasingly rigorous with regards to the detection, identification, and quantitation of...
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Part One: Biologics and the Problem with Residual DNA
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Part Two: Cell-Based Bioassays