Are you faced with challenges in warhead manufacturing?

ADCs are a new and promising generation of the cure of cancer. Recently, ISPE Annual Meeting & Expo hosted a workshop to address the GMP and occupational protection requirements during manufacturing from the warhead to the sterile fill finished ADCs. Our expert, Dr. Srinath Thirumalairajan, Director, GMP Manufacturing presented “Challenges in Warhead Manufacturing” that covered the intricacies involved in the manufacturing of highly potent cytotoxic payloads and containment strategies at various stages of the manufacturing process.

Key Lessons Learned:

• Challenges involved in both small scale and large scale manufacture of cytotoxic payloads
• Control strategies to prevent exposure of personnel to cytotoxics
• How to calculate and establish occupational exposure levels (OELs)/bands for cytotoxics

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