FDA sets aside $700,000 for manufacturing research
pharmafile | July 25, 2011 | News story | Manufacturing and Production |Â Â FDA, pharma manufacturing newsÂ
The FDA has set aside $700,000 to help fund research that “improves reliability of pharmaceutical product manufacturing and quality across the entire industry”.
The initial tranche of award money – allocated as part of the US agency’s Critical Path Manufacturing Sector Research Initiative (CPMSI) – is intended to fund production research projects which can be applied by the public sector.
“Research conducted in pharmaceutical sciences related to product quality is typically kept proprietary,” said the FDA in a Federal Register notice.
Additional funds may be made available in the coming years from the FDA and partner organisations of up to around $7 million a year. The funding is open to research teams from universities and non-profit organisations that are not financially supported by industry.
“This Cooperative Agreement is capable of awarding a total of $35 million over the entire award project period depending upon progress, the need for, and the availability of fiscal year funds,” according to the notice.
The fund is open for projects in a number of key areas covered by the CPMSI, with 13 specified by the FDA proposal with the ultimate aim of improving the reliability of biopharmaceutical production and shortening the time to scale up manufacturing of new medical products.
These include: education and training; standardised approaches to manufacturing and scale-up; new analytical, data gathering and computational methodologies; simulation models for manufacturing techniques and complex drug delivery devices; product formulations for special patient populations; physical properties of active ingredients and excipients; manufacturing techniques for low-dose products; and improved laboratory syntheses.
Phil Taylor
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