Enabling the pharmaceutical industry to implement the world’s most advanced manufacturing practices is the mission of a national consortium of 11 universities funded for that critical research and policy-recommendation role by the Food and Drug Administration, says Dr. Alan W. Seadler, associate academic VP for research at Duquesne University and treasurer of the National Institute for Pharmaceutical Technology and Education.
Focusing on the key aspects of testing and quality assurance during manufacturing, Dr. Seadler says that the Institute focuses on this issue: “When we are rolling out millions of tablets or doses of compounds, what kinds of information can we get back to guarantee that the material coming off the line is the material that was approved in clinical trials?”
While producing some of the most advanced products, pharmaceutical manufacturers–in the United States and worldwide–work within a framework of regulation that must create a consensus for change in basic ways of doing business. And so the work of the Institute, whose members are meeting this week with members of Congress and the FDA to discuss needed changes, consists not only of research to identify best manufacturing processes but also essential diplomacy and stakeholder management to build consensus and implement change, Seadler says.
In identifying changes, Seadler cites the need for shifting from current dependence on batch sampling to more efficient methods of real-time quality testing of products moving through the manufacturing process.
“If something odd happens, it may not be completely evident in the batch testing,” he says. “Or if a batch fails, you end up throwing away all product made to that point, which adds to the inefficiency. The challenge is to bring pharmaceutical manufacturing up to what we see in other advanced industries. But even more important is working with regulators and industry to agree upon how to upgrade without disrupting the production process–and also to reach forward to the new biotechnology industries.”
Source: Duquesne University, Alan Seadler
Writer: Joseph Plummer
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