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Challenges in Scaling Up Newly Developed Microbial Manufacturing Processes

Presented at: BIO Process Zone Theater San Diego, CA, June 20, 2008

This presentation describes an approach that can save time and money for companies developing unique products expressed in microbial systems. The approach streamlines development and scale up of a microbial manufacturing process. Usually, biopharmaceutical manufacturing processes that utilize microbial production cell lines are developed individually for each product. Due to the unique structure and behavior of the target protein, platform processes are usually not applicable to microbial systems and therefore the development timeline can be longer. The streamlined process utilized an E. coli production host and was developed at the 5-10 L scale. The parameters for the scaled up production were fixed based on multiple process demonstration runs at the smaller scale. Fermentation scale up to the 1000 L scale was seamless in most parameters due to the wealth of information obtained at the small scale. Some unit operations in recovery and downstream process did not transfer perfectly and these are described and reviewed to identify small scale activities and approaches that would increase the success rate of scaling up these steps. The overall program and GMP manufacturing were very successful, demonstrating that there is not a need for intermediate scales but that with rigorous development and testing at small scale, transfer directly to the large scale manufacturing plant can be performed.