The Future of Media Development
Biopharmaceutical companies are beginning to take a responsible approach to media formulation, and significant effort is being
invested in the development of well defined, animal-origin free alternatives. It is important, however, to establish actual
risk when deciding the level of animal-origin free components beyond the primary level. If a critical or expensive bioproduct
such as insulin is to be manufactured, then the biopharmaceutical manufacturer may well be justified in setting raw material
specifications. Many are seeking secondary level animal-origin–free insulin despite the injectable being a primary level product.10 This shows that before considering the animal-origin–free level of a raw material, it is important to review all aspects
of the process and determine the overall potential risk of the product.
A shift toward the universal use of chemically defined media is a beneficial step forward in the long term. Companies must
be prepared for a change in regulatory guidelines, which may include a ban of animal-derived components from biologics manufacturing
or stipulate a complete chemically detailed profile of raw materials used in the process. Either way, a chemically defined
process must be the ultimate goal of all biopharmaceutical companies, helping them meet their goal of balancing media development
with patient safety.
MICHELLE LEA, PhD, is a senior fermentation development scientist at Eden Biodesign Ltd, Liverpool, UK, +44 151 728 1750, email@example.com
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