Quality by Design Pilot for Biotechs Will Focus on Comparability Protocols, Winkle Says

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA’s Center for Drug Evaluation and Research, said on September 20, 2007.

“We’re going to give companies submitting comparability protocols a chance to provide us with information on product development and manufacturing processes that feed into the whole concept of Quality by Design,” Winkle said in a podcast interview with BioPharm International (see www.biopharminternational.com/biopharmnow). The reason for focusing on comparability protocols is that the Office of Biotechnology Products (OBP) does not receive a large number of marketing applications each year for biotech products.

Winkle said she is pleased with the progress of the ongoing QbD pilot for small-molecule drugs. That pilot, conducted by the Office of New Drug Quality Assessment (ONDQA), was first announced in July 2005, and accepted filings until March of this year.

“We are making a lot of headway with getting a lot of companies to participate in the ONDQA pilot,” she said. “They’re beginning to send in information to us in their applications which can help us in identifying some of the things that we need for the future of Quality by Design.”
 
The office has learned a number of things from that pilot, such as what problems manufacturers face when trying to identify critical quality attributes. “I think we can take those lessons learned and utilize those in making sure the pilot we have ongoing in OBP really meets our needs,” Winkle said.

The Federal Register notice announcing the biotech pilot will be published soon, Winkle said. “In the next two or three months, we hope to be able to start accepting applications from biotech companies with Quality by Design information in them,” she said.

Hear the podcast at www.biopharminternational.com/biopharmnow