PTI's CMC training course will provide a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products.
Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated ...
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...
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