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Meeting the Challenges of Applying PAT to Biopharmaceutical Manufacturing

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Presented by: Susan Dana Jones, PhD
BioProcess Technology Consultants, Inc.

While Process Analytical Technology (PAT) has been used for decades to ensure process reproducibility, applying PAT to biopharmaceutical manufacturing is much more complex due to the complexity of biomolecules and the batch to batch variability resulting from slight environmental changes during production. Standard analytical methods for monitoring cell culture conditions, such as NIR, pH, or DO2 do not measure product concentration or quality. As HPLC methods can generally be developed to provide this information, a reliable, informative on-line HPLC method would be a very useful PAT method for biomolecules. In this webinar, examples of PAT in biopharmaceutical manufacturing that takes advantage of the unique properties of specially designed CIM monolithic HPLC columns to provide rapid, actionable information will be presented. These will demonstrate the utility of this robust PAT to speed up development and optimization of both the upstream and downstream processes. These methods can later serve as accurate methods that provide actionable data during manufacturing.

Meeting the Challenges of Applying PAT to Biopharmaceutical Manufacturing

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