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A Practical Design

In recent years, regulators have been encouraging pharmaceutical and biopharmaceutical companies to incorporate the concepts of quality by design (QbD) and process analytical technology (PAT) into drug development and manufacturing processes (1). This should be seen as part of an ongoing drive for scientists to gain as much knowledge and understanding about a new drug as possible (rather than simply collecting the data required for the formal approval process) using a considered set of critical process parameters (CPPs) to subsequently control production.

Now well-established in the ‘small molecule world’, biopharma has been much slower to adopt these concepts, and, to date, few drugs have been filed based on QbD data. Industry experts have hypothesised that the nature of biologics brings with it more complex quality concerns and a significantly higher number of input parameters that can have an impact on product quality. As a result, the implementation of QbD within biopharma calls for a significant level of detailed information gathering.

Kurt Pickle at IDEX Health & Science (October 2019)

Keywords: IDEX Health & Science, Chromatography, Separation, Biopharma, Drug development, PAT, Quality by Design, Small molecule

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