Navigating the Biopharmaceutical Regulatory Pathway: Replacing Undefined Raw Materials with Chemically-defined Substitutes

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With market demands increasing, biopharmaceutical producers are constantly looking for ways to enhance product quality while reducing costs and risk. One way to meet these changing demands is to replace animal-derived supplements with chemically-defined substitutes. In this educational webcast, Dr. Michael Titus, Director of Quality Management and Regulatory Compliance with BD Biosciences, outlines the regulatory pathway involved in making such a switch. Dr. Titus will discuss:

• A background on the uses of supplements in the cell culture production process;
• Change control & risk management;
• And the regulatory path of making the switch to chemically-defined supplements.

Join Dr. Titus as he demonstrates how chemically-defined supplements can boost performance, reduce risk and increase consistency in commercially marketed biopharmaceutical products.

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