FDA grant aids manufacturing, regulatory science

The FDA is putting up $700,000 in grant money in an attempt to improve "the manufacturing and quality knowledge base" for drug-making. The funding supports a collaboration between the agency and the not-for-profit National Institute for Pharmaceutical Technology and Education on developing the FDA's Critical Path Initiative, according to a posting last week in the Federal Register.

NIPTE is a research/education organization devoted to greater understanding of the science and engineering behind drug development and manufacturing to improve both drug-making technology and regulation. The FDA says the research is needed to improve pharma manufacturing "across the industry."

The efforts to be supported include the development of analytical and computational methods to better characterize complex molecules and mixtures for greater control of manufacturing processes and product quality; research to improve techniques for collecting and analyzing process data for process-control purposes; standardized approaches to ensuring product quality using manufacturing and analytical data; and creating simulation models for such manufacturing techniques as fermentation and cell culture, small molecule crystallization, freeze drying and precision tablet coating.

- here's the Federal Register notice

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.