While current guidelines encourage antibody and vaccine makers to source bomaterials from countries where cases of Bovine spongiform encephalopathy (BSE) are rare, there is no legal requirement that they comply with this advice.
As a result many producers still use blood from cattle in cheaper – but higher risk – places to produce their bovine serum materials according to Rocky Mount Biologicals CEO Suresh Daniel, who wants regulators to force them to source from low-risk – or category A – destinations such as Australia or New Zealand.
Daniel cited recent events like the US Government's closure of a slaughter house that had supplied material for public consumption from cattle at risk of BSE as an example, telling in-Pharmatechnologist.com that: “One would think that it would provide more impetus to use BSE-free raw materials in the manufacture of biologics and vaccines.”
However, following a recent meeting with the US Food and Drug Administration FDA he told us “they are unwilling to enforce their action,” adding that other authorities like the European Medicines Agency (EMA) are of a similar mindset.
In a further email conversation with the FDA – which Daniel shared with this publication – he quizzed the regulator, asking: “Is the FDA willing to enhance the safer supply of blood fractions used in human pharmaceuticals in order to protect the US population which the FDA is intended to serve?”
The FDA admitted it “is aware of the uncertainties regarding BSE and we make every effort to incorporate that into our thinking.”
Daniel also probed the EMA in a string of back-and-forth emails, in which he told the organisation: “Those companies which are are embedded in the manufacture of Cat B (less safe) do not claim that an alternative exists and continue to pose a risk for those who utilize and rely on the pharmaceutical product to be the safest possible.”
The EMA directed him to its guidance, which states: "Whether there is a choice, animals should be sourced from countries with the lowest possible BSE risk (negligible BSE risk countries (Category A)) unless the use of material from countries with BSE risk is justified.
"Some of the materials identified in Section 6 of the above referred guideline, ‘Specific conditions’ can be sourced from countries with controlled BSE risk (Category B) and in some cases from countries with undetermined BSE risk (Category C), provided that the controls and requirements as specific in the relevant sections are applied."
From an industry perspective, we asked Daniel why he believes some firms are sourcing products from areas of higher risk.
He replied: “I don’t know. In terms of cost of product there is no difference in cost between Australia and Zealand, and its safer than a US domestic source.
“I think there is a lack of desire to change. The cost to change in manufacturing setting for approved product and method is a lot. There is also a lack of awareness about the risks.”