Views from the Trenches

Peers offer their opinions on standards for heparin

Professionals in the pharmaceutical industry, speaking anonymously, have their own views of the heparin case. One notes the need for much stricter standards: “I recently spoke with a colleague who argues that future drug specifications include values for known degradation products, unknown degradation products, and a limit for undetected degradation products.” He notes that this only prompts the question: “How can we set a limit on, let alone measure something that we do not know exists?”

“Many companies are doing due diligence with multiple methods and/or orthogonal methods to ensure to a high degree of probability that all potential impurities in each lot of API or DP are quantified appropriately,” he goes on. “As far as looking for potential adulterants—specifically, I would say a limited number [is possible], but my sample size is not the entire population distribution. For API/DP sourced internally, I would say no. Based on all of the current issues with materials from China and other developing regions, a lot of focus is being turned to what we need to ensure that the materials meet incoming material specifications. As an alternative, many, I believe, are beginning to rethink their strategies for sourcing APIs, intermediates, excipients from these lower cost providers.

“We know what is in a drug product as it leaves us and during environmental exposures.  What we can only react to is if things are done to it externally—that we also have a good track record on (identifying adulterants and taking action) but it is nigh impossible to control a priori.

Another reader notes that API testing, beyond crystalline form, is not yet required. Yet another expert, who formerly worked for a Big Pharma company, noted that quality can be hampered by the entrenched belief, in biotech, that the process is the product. This person was working on a product that uses heparin as its primary raw material, and advocated raw material conformity testing. The bio group expected to deal with variation, so they made a dirty “intermediate, but the process is expected to clean up the product. It would have been interesting if the raw screen was in place and if it would have picked up any adulterants,” this person says. “I think raw material conformity would have [picked them up] but RM verification wouldn't have,” he says.

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