FDA Awards NIPTE Multimillion-Dollar Research Grant

Last week, FDA awarded a grant to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug development and manufacturing. The grant could be worth as much as $35 million over the next five years. Using the grant, NIPTE will conduct research in various areas, including methods for reducing time to market, enabling new performance attributes in drugs, improving small-batch production, and promoting continuous manufacturing.

The FDA-funded projects are intended to improve the science and technology for drug development and manufacturing. The goals include reversing the trend of pharmaceutical outsourcing by decreasing the cost of manufacture and improving drug quality and safety. The research is also intended to help reduce healthcare costs, create jobs, and help improve the country’s manufacturing competitiveness.

“Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing,” said Helen N. Winkle, director of FDA’s Office of Pharmaceutical Sciences, in a NIPTE press release. “Progress in this area will mean safer, more efficient, and less costly drug production here in the US, and we are looking forward to NIPTE’s findings.”

FDA will identify specific projects for NIPTE to pursue, and will also approve project proposals drafted by NIPTE faculty. The proposed general topics for research include the following:

• The development of platform strategies for medical-product manufacturing to shorten timelines for commercial-scale production

• The development of analytical and advanced computational methods to better characterize complex molecules with a view to enhancing understanding and control of manufacturing processes and product quality

• The creation of simulation models for manufacturing techniques, including biotech fermentation and cell culture, small-molecule crystallization, freeze-drying, and precision tablet coating

• The study of the physical characteristics of active pharmaceutical ingredients and excipients, such as crystal morphology, cocrystal technology, dispersions, and particle sizing, including nanotechnology

• The development of specialized manufacturing techniques for products administered in low dosages and for products with high toxicity or narrow therapeutic ranges.

NIPTE’s project leaders and faculty members will provide FDA with research updates on a regular basis. FDA will offer feedback and suggest how the research may need to be changed. All of NIPTE's research results will be published in the literature.

The cost of drug manufacturing could be reduced significantly with good science and technology, according to Prabir Basu, executive director of NIPTE. The organization’s work is intended to improve the quality and safety of drug supplies and supply chains. “If we have good science, and if we can implement quality by design, then irrespective of where the product is going to be made, the quality would be more assured. If we can develop state-of-the-art science for pharmaceutical development and manufacturing, there’s going to be less outsourcing, and even if there’s outsourcing, higher quality would be assured,” says Basu.

The FDA grants will give a needed boost to translational research. “The science of pharmaceutical technology has been really neglected, and that’s why we have all of these problems in manufacturing,” says Basu. “I hope this is a turning point for this industry. I also sincerely hope that other federal agencies like the National Institutes of Health will step up to the plate and start funding translational research in a much more significant manner,” he adds.

NIPTE is an academic, not-for-profit organization that conducts research about pharmaceutical product development and manufacturing. The group aims to increase science and engineering-based understanding, foster the development of innovative technologies, and aid the implementation of science-based regulations.