FDA Awards NIPTE $1.19 M for QbD Guidance Project

West Lafayete, IN (Oct. 29)-The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

The two-year project will provide background information for a future guidance document. "We see this as a beginning," says Prabir K. Basu, NIPTE executive director. "At the end of the two-year project, we hope to hold an open workshop with industry and academia. One of the conditions of the funding is that the research knowledge gained from the project will be available to the public."

The project will involve taking gabapentin (marketed as “Neurontin” by Pfizer) as the prototype compound active pharmaceutical ingredient through blending, granulation, and drying operations. According to Basu, the project will aim to answer two fundamentally important manufacturing questions: "How do these unit operations scaleup (i.e., How can one develop a design space from one scale to the other)?" And, "How does scale-up influence stability?"

The project will begin at the laboratory scale (5 k) and be scaled up to the 30-60 k size, with stability being monitored at each unit operation.

The focus of stability is a major part of the project, mainly as a result of the industry concerns about safety. “Manufacturing is not always a major focus when healthcare issues come up,” says Basu. "We believe manufacturing is probably the hidden crisis in healthcare. Some of the stability issues that we are seeing today are a result of manufacturing. For example, the recent heparin contamination issue was essentially a manufacturing issue. We believe that by improving manufacturing, making it more reliable by using quality by design, we can ensure drug safety. By actually doing the design space and QbD, we can have a better understanding of stability.”

Of the 11 member universities that comprise NIPTE, the major institutions that will be involved in this project are Purdue, Duquesne University, Rutgers, Illinois Institute of Technology, University of Iowa, University of Kansas, and the University of Minnesota.

“We have put groups together consisting of well-known engineers and scientists,” says Basu. For example, the design-space portion of the project will be led by James Drennan (Duquesne Univ.), Fernando Muzzio (Rutgers), Hamid Arastoopour (IIT), and James Litster (Purdue). The stability testing portion of the project will be led by Lee Kirsch (Iowa), Eric Munson (Kansas), and Raj Suryanarayanan (Minnesota). Overall API development will be directed Robin Bogner (Connecticut) and Rex Reklaitis (Purdue).

The award follows a separate $94,500 FDA seed grant for developing a QbD framework for parenteral products. NIPTE aims to expand this project in 2009 to develop guidance elements for parenterals. Basu also says NIPTE plans to apply for future grants to expand this project, possibly including the tableting step, or to start similar projects.

This is a corrected version of the original story, which clarifies a quote by Prabir K. Basu.