FDA offers grant to improve biopharm production steps

Creation of the Critical Path Manufacturing Sector Initiative is intended to stimulate research into biopharm manufacturing. As part of the initiative the US Food and Drug Administration (FDA) is offering a research grant to a project that can improve biopharm production across the industry.

“[Projects should] improve reliability of pharmaceutical product manufacturing and quality across the entire industry. This shared knowledge will increase the likelihood of successful manufacturing​”, said the FDA in a post in the US Federal Register​​.

All proposals should further this goal but the FDA has left a lot of scope for the exact details. Research goals can fall into 13 categories outlined by the FDA in the grant document.

Possible projects​

Improving understanding of manufacturing scale-up is the focus of two goals: proposals related to scale-up training for product developers and academics is one aim; the other is development of publically available models to guide small business through production scale-up.

Creation of simulation models, for delivery devices or manufacturing processes, such as cell culture, are two more of the objectives. As with the scale-up models, the FDA hopes creation of these simulations will shorten timelines and make processes more predictable and lower risk.

Gaining an understanding of the characteristics of ingredients, both active and excipients, is another goal shared by multiple categories. A possible project in this area would be the development of technology to control characteristics such as crystal morphology and dispersions.

Applicants have until July 20 to send proposals. The FDA expects work on the successful project to begin on August 31. Only one project will receive backing and $700,000 (€497,000) is available in fiscal 2011, although much more funding could be offered over the life of the project.