Media Products And Feeding Strategies Improve Productivity In Biomanufacturing Industry
By Liisa Vexler
Biomanufacturers in the early 2000s predicted a shortage in manufacturing capacity in the not-too-distant future. Biotechnology companies sourced out 10-20 kL bioreactors made of stainless steel, while process developers continued to improve titers by ever-increasing factors, from 2, to 5, to 10. As such, the capacity issue never unfolded as predicted. Global experts ascribe the increase in productivity to the development of breakthrough media products and feeding strategies.
Cell culture media that is worthy of bioproduction continues to get better, and thus bioprocessing companies are reaping the benefit of enhanced processing methods, increasingly high titers, and the opportunity to use diverse single-use containers for production.
The focus on global process related to cell culture rather than the maximizing of single unit operation has indicated a change in focus for bioprocessors. Megan Norris, GE Healthcare’s general manager for upstream products says, “This [shift in focus] represents a distinct trend upstream. Five years ago, we were still worried about titer. Today, the concern is on overall process yield and quality, as well as the culture media constituents that affect the efficiency of downstream steps.” This refocusing in the industry means that companies that manufacture media, like GE Healthcare, must come up with ways to make purification more efficient.
However, a key challenge facing the industry as it moves towards flexible manufacturing is that processes occur in small scale. This change can be mitigated by higher titers. Single-use bioreactors are limited to approximately 2,000 L, and thus bioprocessors taking advantage of flexible manufacturing systems must stay financially viable when scaling single-use setups. “We must also assure that we’re not simply pushing up the yield and kicking problems down the road to downstream operations,” Norris explained.
A critical focus for large-scale biomanufacturing companies is now understanding the culture medium’s raw material components, and how the media components have an impact on product quality.