Process Decision Support Using Fundamental Understanding : Upstream Bioprocess Applications
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- 05/05/2022 - 11:00 am - 12:00 pm CDT
Bioreactors are a critical upstream processing operation in the production of a wide range of biopharmaceuticals (MAbs to C&G Therapy products). Operating bioreactors in a robust and reliable manner eases pressure on downstream processing steps, thus increasing overall process reliability and product quality assurance. The only meaningful path to ensure reliable bioreactor operation is via a thorough and pragmatic fundamental understanding of the reactor’s capabilities.
In this webinar, we will discuss
a) What fundamental process understanding means and why “process metrics” are the best way to represent process understanding.
b) How to determine process metrics for various bioreactor systems In addition, attendees will learn how to use process metrics to support the following activities: – scale-up – smart design of experiments – process data analysis (including historical process data and experimental data) – scale-down analysis – operations support
We will also illustrate these easy-to-implement methodologies using COTS single-use bioreactors from major vendors (Sartorius, Millipore, Pall etc. to name a few).
We will further show how the information from characterization studies can be used to support process development and technology transfer activities.