The concept of “peak serum” in cell therapy products manufacturing

by Alexey Bersenev on December 15, 2011 · 0 comments

in cell culture, cell product

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I’m sure everybody heard of the “peak oil” concept. Analogous to “peak oil”, David Brindley and co-authors have proposed so-called “peak serum” concept in cell therapy manufacturing. You can read their proposal in today’s issue of Regenerative Medicine journal:

We propose that the global serum supply has reached somewhere near its peak, and this is occurring at the same time as the CTI enters its first sustainable period of growth. There is certainly a pressure across the entire industry to reduce or remove serum from bioprocessing, driven by the perceived US FDA aversion to the presence of animal-derived components in cell culture. However, here we argue that the use of serum in commercial-scale cell therapy manufacturing is less of a regulatory issue and more of a major supply issue.

Chris Mason has called cell therapy industry professionals today:
December 15, 2011

The part of author’s proposal is use of serum exclusively for master cell bank, but not for specific cell product manufacturing:

In conventional, allogeneic cell banks that generate 100–300 master cell bank vials, less than 1% of all media (and thus serum) is used to generate the cell bank, compared with the total media required to produce all final products manufactured from that cell bank. Thus, 99% of all serum could be removed from the overall manufacture of a specific cell therapy by initially using serum in the production of master cell banks, but subsequently reverting to serum-free protocols for all post-cell bank expansion and processing.

We have written about adverse effects of animal products on cell culture. Despite the safety precautions, animal serum still used in cell products manufacturing. No doubt, the “peak serum” will accelerate shift to serum-free protocols development. So, I think the “peak serum” is a good thing. Regulatory (linked to safety), supply issues or both together inevitably will lead to “serum-free era”.

Finally, I’d sign under each word of this conclusion:

The progressive reduction in serum utilization is highly desirable from both clinical and manufacturing perspectives. The serum-related issues; safety, efficacy, scalability and cost of goods are factors critical to the future success of cell-based therapies. The use of serum and its pragmatic reduction and eventual elimination are essential and achievable steps in the development of a sustainable and competitive CTI.

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