Balancing Media Development with Patient Safety - - BioPharm International


Balancing Media Development with Patient Safety

BioPharm International Supplements

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,


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