Balancing Media Development with Patient Safety - - BioPharm International

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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,

References

1. Lee K. A media design program for lactic acid production coupled with extraction by electrodialysis. Bioresource Technol. 2005;96:1505–10.

2. Grosvenor S. The role of media development in process optimization: An historical perspective. BioPharm Int. A Guide to Protein Production. 2008 Jun suppl;28–37.

3. Stanbury PF, Whitaker A, Hall SJ. Principles of fermentation technology. Oxford, UK: Butterworth-Heinmann Press; 2000; p. 74–90.

4. Hahn-Hägerdal B, Karhumaa K, Larsson CU, Gorwa-Grauslund M, Görgens J, van Zyl WH. Role of cultivation media in the development of yeast strains for large scale industrial use. Microb Cell Fact. 2005;4:31–46.

5. Helle SS, Murray A, Lam J, Cameron DR, Duff SJ. Xylose fermentation by genetically modified Saccharomyces cerevisiae 259ST in spent sulfite liquor. Bioresource Technol. 2004;92:163–171.

6. Van Niel EWJ, Hahn-Hägerdal B. Nutrient requirements of Lactococci in defined growth media. Appl Microbiol Biotecnol. 1999;52:617–27.

7. Hammet K, Kuchibhatla J, Hunt C, Holdread S, Brooks JW. Developing chemically defined media through DOE: complete optimization with increased protein production in less than 8 months. Cell Technologies for Cell Products. Springer. 2007; 683–91.

8. Ham RG. Clonal growth of mammalian cells in a chemically defined synthetic medium. Proc Natl Acad Sci. 1965;53:288–95.

9. Pamukcoglu T. A risk-based approach to establishing animal-component-free facilities. BioProcess Int. 2009 Dec;7(11):54–7.

10. Madigan LE, Donahue-Hjelle L, Nampalli SS, Stramaglia MJ. Strategies for sourcing animal-origin free cell culture media components. BioPharm Int. Guide to Outsourcing. 2009 Apr;34–37.


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