Advances in Animal-Free Manufacturing of Biopharmaceuticals - New recombinant raw ingredients developed for use in large-scale mammalian cell culture are becoming readily available. - BioPharm

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Advances in Animal-Free Manufacturing of Biopharmaceuticals
New recombinant raw ingredients developed for use in large-scale mammalian cell culture are becoming readily available.


BioPharm International


ADVANCES IN RECOMBINANT PROTEIN ALTERNATIVES

With the construction of further barriers to the use of animal-derived materials, there are growing needs and trends in the industry to move toward the use of serum-free, chemically defined, and most recently, protein-free media formulations for use in mammalian cell culture. Using chemically defined media components not only reduces the risk of introducing adventitious agents, but it also assists both upstream and downstream process optimization.

While major advances have been made in this area, there are still drawbacks to the use of these products, especially for industrial-scale culture.5,6,7 Transfer to serum-free or protein-free media can be very stressful for cells, and it typically requires a period of adaptation or "weaning." Successful adaptation can be time-consuming and cell-line-dependent, and a lack of protein components can lead to a less robust and less reproducible process.

It is recognized that the addition of specific growth factors and proteins (which are naturally found in serum) can enhance cell viability and productivity. Serum-free media, which is still used extensively in research laboratories, can contain proteins that may or may not be animal- or human-derived. Similarly, to enrich protein-free media, hydrolysates may be added that are not always non-animal in origin.

Recently, dedicated research and development into the production of defined, recombinant alternatives to three critical components of serum (insulin, transferrin, and albumin) have led to a range of animal-free recombinant protein ingredients that are designed and manufactured specifically to optimize mammalian cell growth and productivity at the industrial scale. With these ingredients, researchers should now be able to achieve the performance associated with protein-supplemented media while avoiding the associated risks of traditional animal-derived supplements.

Studies with recombinant ingredients have shown equivalent or improved performance in a wide range of cell types up to commercial scale.8,9,10 Manufactured to recognized quality standards and offering continuity of supply, these ingredients provide the confidence in critical raw material quality that is required of products used in long-term biopharmaceutical manufacturing.

Recombinant Insulin-Like Growth Factor

Growth factors are essential for long-term growth and proliferation of cell lines in serum-free media formulations. Recombinant therapeutic insulin has been used as a growth factor in serum-free cell culture. However, its primary use for the treatment of diabetes has led to supply and availability issues for cell culture users.

Recombinant insulin-like growth factors are now available as a dedicated raw material, manufactured exclusively for the industrial cell culture market. Studies using this mitogen as a supplement in cell culture have shown that it results in performance that is equivalent to or better than recombinant insulin in numerous cell types, including: Chinese hamster ovary (CHO), baby hamster kidney (BHK), human embryo kidney-293 (HEK293), Vero, PER.C6, Madin-Darby canine kidney (MDCK), and fibroblasts (data not shown).


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