CDMO Insights

cGMP for your clinical batch

Find out why manufacturing best practices are critically important to your product’s transition from drug substance to human-ready clinical material.

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Key insights in this video

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How cGMP manufacturing processes work for early-phase fill and finish

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Key cGMP guidelines for clinical manufacturing

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Three fundamental components of a comprehensive quality system.

Need to fill your clinical trial supply? See why now is the time for cGMP-compliant manufacturing processes.

For an injectable medication, the shift from preclinical to clinical development comes with a range of new procedural, logistic, and regulatory considerations. First and foremost: how to not only produce enough of your drug substance to supply your trials, but do so in a way that meets all quality and safety standards for in-human use.

In this video, you’ll learn how and where to start aligning with key manufacturing standards for clinical material – and why an expert partner can be a critical asset during this step.

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Dr. Gerhard Reuter, Qualified Person
Dr. Gerhard Reuter

A cGMP expert explains where to focus and why

Gerhard Reuter is a veteran quality specialist who plays a critical role in authorizing the release of medical product batches, and also oversees the quality systems used to produce them.

Sign up today to get his in-depth insights on the cGMPs that matter most for clinical-stage injectable medications, and how an early focus on compliance can help support future regulatory success.

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