Lessons in Bioreactor Scale-Up (Paperback)

Bioreactor scale-up in pharmaceutical science refers to the process of transferring optimal conditions obtained in small-scale, often high-throughput, bioreactors to large-scale bioreactors. It involves considerations such as mass and heat transfer phenomena, tech transfer, and defining and validating operating conditions. The goal is to ensure product quality and facilitate seamless scale conversion. Cell culture bioreactor scale-up is a critical step in the production of biologics such as therapeutic proteins, monoclonal antibodies, and vaccines that are administered to patients suffering from various diseases. It involves translating laboratory discoveries to large-scale industrial applications, while maintaining product quality and cost-effectiveness. Bioreactor scale-up in bioprocessing industry involves transitioning from miniaturized, high-throughput bioreactors to larger bench-scale, pilot- or production-scale bioreactors. It is a pivotal aspect of modern biotechnology, allowing lab discoveries to be developed and applied industrially.

• Bioreactor scale-up is a critical step in the production of biologics such as therapeutic proteins, monoclonal antibodies, and vaccines.
• This valuable process involves translating laboratory discoveries to large-scale industrial applications, while maintaining product quality and cost-effectiveness.
• Bioreactor scale-up in chemistry involves transitioning from miniaturized, high-throughput bioreactors to larger bench-scale and pilot- or production-scale bioreactors.
• A pivotal aspect of modern biotechnology is allowing lab discoveries to be applied industrially.
• Bioreactor scale-up sustainability involves improving fermentation production processes and bioreactor technology to reduce costs, create compelling products, and scale the industry.
• Geometric similarity in bioreactors is crucial for successful scaling-up.

Muhammad “Arshad” Chaudhry is working as Director – Cell Line and Upstream Process Development at Disc Medicine for the past one year. Prior to that, he has worked in various roles in upstream processing, covering a wide range of biologics (monoclonal antibodies, fusion proteins, allogeneic cell therapy, lenti and AAV-based viral vectors, etc.). He has been in the cell culture field for almost 20 years now and has worked mostly in the upstream process development supporting both early and late-stage projects covering CMC activities, GMP manufacturing of clinical-grade material, QbD-based scale-down model development, and process characterization studies. He holds a Ph.D. in Biochemical Engineering from University of British Columbia, Vancouver Canada having worked under Dr. James Piret’s guidance on embryonic stem cell bioengineering and fed-batch process development projects.