The biotech industry has experienced consolidation over the last several years, says Bruce Lehr, director of global marketing at SAFC Biosciences. “A smaller number of large companies are emerging as major players, and within those the tendency is to develop their own cell-line production platforms and the media and feed as well.”
In the past, media companies were more involved in the design of client-specific media development and enjoyed a robust business from smaller biotech companies. Today, companies with promising late-stage products are being rapidly acquired by larger pharmaceutical or biotech firms that tend to perform their own media development. Vendors like SAFC assist in media development wherever they can but are increasingly being called upon to manufacture media and feeds that companies develop on their own.
Development-stage companies that for financial or logistics reasons cannot invest in costly and complex media development still outsource these activities, reports Lydersen. “The methodology used to optimize both the basal media formulas and the concentrated solutions used in fed-batch fermentation processes is evolving rapidly,” with increased emphasis on robotics (for generating large numbers of samples) and metabolomics to determine rate-limiting metabolic pathways within the cells. “But in addition to these emerging technologies, media optimization still relies on scientific insight and practical experience to optimize media for specific clones.”
Once a medium is developed, vendors are called upon to assess manufacturability, to eliminate animal-derived components, and, whenever possible, to substitute chemically defined ingredients or whole media for animal-derived components and plant hydrolysates. Chemically defined media do not attempt to duplicate all the ingredients of media derived from animal products, yeast, or plants. Instead, they are based only on the ingredients that are confirmed active and essential to cell growth or productivity. “The idea is to deliver a consistent product each time,” Lehr says.
With all the buzz over animal-free components it becomes easy to forget traditional media. Academic and government researchers still use classical culture media, so media suppliers need to provide products that meet these needs as well.
Media specialty firms are, in addition, expected to solidify the media/feed supply chain, help customers source raw materials, provide traceability, and conduct additional analytical or biological testing to assure that the materials are fit-for-purpose in their intended application.
Last year, SAFC introduced CD Fusion Hydrolysate, which directly replaces plant and yeast hydrolysates in many CHO-cell applications. CD Fusion Hydrolysate has been enthusiastically received by industry, according to Lehr, and several customers are qualifying the media for late-stage manufacturing.
Another product, CHO CD fusion medium, is a complete, chemically defined medium for growing CHO cells for use in therapeutic production while maintaining cell growth and productivity.