Securing the Supply Chain - A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials. - BioPharm International

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Securing the Supply Chain
A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials.

BioPharm International Supplements
Volume 26, Issue 3, pp. s8-s9

QUALIFYING RISK

BioPharm: Can you talk more specifically about raw materials that go towards biologics, such as media supplements?

Backer: As with anything, there are certain products that go higher up on the risk profile than others. When you think about high-risk products, you think about serum, media, or animal-sourced materials. Serum gets additional scrutiny, as does something like trypsin. Also, there are hydrolysates that go into media that we want to make sure are not only effective but are protected. Increasingly, there's a move toward chemically defined media to get these higher risk supplements out of the system, if at all possible. The reality is that it's not always possible. I'm not in the stem cell business, but it's my understanding that stem cells don't grow very well without serum. Will stem cells get to the place where a lot of biologics are now, where they don't need these supplements? Possibly, but we're in early days. With that reality, we want to make sure we mitigate those risks, which is why testing is so important.

Garrett: You're seeing manufacturers begin to stratify their raw materials by those that are highest risk, which are truly animal derived. They want to eliminate those if possible, but if they cannot they want to mitigate those risks as much as possible through various pretreatment regimens or at least through the kind of testing BioReliance provides. After animal-derived products you have plant-derived materials, which are generally considered to be less risky but may contain adventitious agents that may or may not have potential downstream issues. You then can look at what goes beyond that—various organic and inorganic salts and chemicals that go into the product. There's also a lot of work that goes into the downstream process. Downtream processes are designed to ensure that if there were something in the product, the downstream process would mitigate it, and that the process creates a safe product in its final form.

From the raw material side, you'd say that people are concentrating on risk management—to get rid of risky products where they can, and where they can't, to qualify those risks as well as they can.


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