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Where are we going? Trends in Biomanufacturing Processes and Facilities Discussed at PepTalk 2014

This year’s PepTalk conference covered a variety of topics, ranging from antibody engineering and the development of new protein and antibody products to critical issues in protein formulation, delivery and packaging to current and emerging trends in process and design for improved manufacturing efficiencies. During my talk , I presented BPTC’s current biomanufacturing capacity projections showing an increase in facility utilization from around 50% in 2012 to approximately 85% in 2018 if nothing but current facility projects are completed in this timeframe. This squeezing of capacity availability is compounded by the concentration of capacity in just a few companies potentially leading to a situation where companies with limited or no capacity will have difficulty securing suitable manufacturing capacity for their products. This will clearly be a driver for a new round of large scale capacity expansions, such as those recently announced by Samsung Biologics, Amgen, and Roche/Genentech, as well as an impetus for the construction of a number of smaller facilities, especially in emerging markets.

The convergent of trends in new product development towards more personalized or niche products and more efficacious products such as antibody drug conjugates with improved cell line productivity and process intensification and advances in single use technologies have led to a paradigm shift in the industry’s approach to facility design and construction. Today’s biopharmaceutical production facilities must be flexible, cost effective, and readily constructed with minimal capital investment and construction timelines. These drivers for new facility design and construction were emphasized not only by me but also by Peter Cramer of M+W and others during a session devoted to Trends, Requirements, Economics and Design Considerations for Modular, Flexible Facilities.

Both Sedetin Ozturk (MassBiologics) and Jens Vogel (Boehringer-Ingelheim) discussed advancements in process intensification leading to more efficient manufacturing processes producing more product in less time. Improvements in product titers are obviously one driver in this area but so too is the potential of continuous processing. As Drs. Ozturk and Vogel noted, switching from the current industry standard fed-batch operations to continuous perfusion cell culture leads to much higher cell densities in the bioreactor and greater productivity of a facility. Coupling such high titer perfusion processes with continuous downstream processes will also lead to further process intensification from improved utilization of equipment and the use of significantly smaller equipment at all stages of the process. Whether such developments become commonplace in our industry or remain an intellectual curiosity remains to be seen. However, taken to its extreme, widespread adoption and implementation of continuous processing in the biopharmaceutical industry could lead to a radical change in the overall manufacturing landscape.

 

Blog article by: Howard Levine