Yesterday, FDA and the Critical Path Institute announced the formation of a new consortium for drug safety. (This was welcome news, particularly coming so soon after news of some clinical drug trials in the U.K. that didn't turn out too well for participants, and had the media questioning whether people who take part in clinical studies fully understand the risks). FDA and the Institute also released a list of critical projects. Process Analytical Technologies (PAT) figured among them---particularly calibration and operation standards for spectroscopy and standards for Rapid Microbial Monitoring technology. Here were some of the manufacturing-related goals:
- Improving the manufacture of influenza and other vaccines (and stimulating the development of alternatives to egg-based systems) by offering libraries or banks of appropriate, and safe, cell lines.
- Developing biomarkers to characterize cell therapies (such as treatments involving cord blood stem cells)
- Finding new ways to characterize biological products (using NMR, x-ray crystallography or mass spectroscopy) to determine the link between physical characteristics and clinical outcome.
- Detecting contamination in biological products, by using microarrays and other technologies for Rapid Microbial Monitoring and Identification (for an excellent survey of what's available read Eli Lilly's Michael Miller's recent article.)
- Developing techniques to facilitate manufacturing changes for proteins that have been well characterized, so that the impact of manufacturing changes is clear and products made via a new process can be compared with those made using other processes (e.g. biosimilars)
- Developing non-animal-based tests for determining vaccine potency.
- Identifying the safety of excipients
- Developing tools for ensuring manufacturing consistency, and better testing, novel dosage forms (such as patches, inhalers)
- Developing standards for spectroscopic instrumentation, including qualification and calibration requirements for Raman and Teraherz.