Upstream Process Development for Better Yield and Product Quality

The production of biologics typically centers around the upstream process development stage involving the use of Chinese hamster ovary (CHO) cells in a bioreactor. It is necessary to implement a dependable tech transfer method from development to manufacturing scale.

Finding ways to optimize the cost of goods with higher yield and enhanced quality is crucial for ensuring long-term commercial viability. Historically, shake flasks with benchtop bioreactors have been employed for screening and characterizing methods in the early stages of upstream development. However, the increasing interest is focused on the application of high-throughput (HTP) single-use technologies to expedite tech transfer and minimize resource utilization.

Ambr^® 250 high-throughput 24-way bioreactor system integrated with the MODDE DOE software and bioanalyzers can be used at different stages of upstream development and upstream process optimization. Upstream process development, especially testing media, screening feeding strategy and characterizing operating conditions is performed using the resource-efficient tool.

The application of bioreactor vessels with similar geometry and aspect ratio is encouraged to simplify the scaling process between bioreactors. The identification of potential critical process parameters using multi-parallel bioreactors is followed by the definition of acceptable operation ranges. The qualifying mini-scale systems are also used as the scale-down model to mimic the process at larger scales and determine the design space based on the rich statistically relevant data. The generation of reproducible and scalable data shortens the tech transfer timeline for accelerated delivery of products to patients.

Join this webinar where Dr. Ali Abghari will discuss the importance of upstream process development in elevating titer and quality, as well as achieving a robust, scalable process.

Speaker

Ali Abghari, PhD, Senior Scientist, Aragen

Ali Abghari is working for Aragen as a Senior Scientist with 12 years of experience in upstream bioprocess development, growing cells in the laboratory and pilot setting for the production of large molecules. He holds a PhD in Biological Engineering and is currently involved in the cell culture process development. He holds a PhD in Biological Engineering from Washington State University and is currently involved in the cell culture process development.

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