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Manufacture Bioprocessing - Upstream & Downstream

Keys to Consistent Bioprocessing

sponsored by ThermoFisher Scientific

This is a very exciting time in the biopharmaceutical industry. While we continue to see companies investing in new therapeutic proteins and biosimilars, we are also seeing an emergence of gene and cell therapy treatments. Each of these therapeutics present unique complexities in process development, but for all, the development of a robust and scalable bioprocess is critical to process consistency and long-term manufacturing success. Ultimately, it’s all about developing a quality process that delivers the desired performance and product every time.

So what are the main things to consider when developing a robust and consistent bioprocess? The first step is to define what the critical quality attributes (CQA) are for the biologic you are producing. These are typically tied directly to the safety and efficacy of that biologic. But in the case of biosimilars, they may also include other measurements necessary to demonstrate comparability to the novel molecule. Second to the CQAs are the key process attributes (KPAs). These are the measurements that will demonstrate that the process is in control, and may include cell growth and product production profiles. Once the CQAs and KPAs are defined, take a risk-based approach – based on internal experience and publically available information – to determine which process inputs are likely to impact them. In upstream process development, it’s easy to first think about bioreactor parameters such as pH and temperature, but additional inputs to consider should include raw materials, cell inoculum, and processing time.

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About the Author

Serena Fries Smith

Serena Smith is Director of Strategic Customer Engagements at Thermo Fisher Scientific.

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