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ARTICLES
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May 16, 2024
7 Game-Changing Tips for a Successful Technology Transfer
Many biotechnology companies, as well as large pharma companies, use biologic Contract Development and Manufacturing Organizations (CDMOs)..
Mar 26, 2024
Sponsor's Roles & Responsibilities in Batch Review & Disposition
Here is a general guideline for a Sponsor's review of GMP batch records for release to clinic for human studies.
Feb 11, 2024
Ensuring all the Puzzle Pieces Fit in Your Biologics Program: Technical CMC Project Management
In a perfect biologics manufacturing world, a Sponsor would be able to sign a contract with an experienced CDMO and voilà...
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