In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
Rapid Micro Biosystems Inc. scooped up $120 million in a series C financing led by Ally Bridge Group, with participation by Endeavor Vision and existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei. The Lowell, Mass.-based company has earmarked the funds to expand the global footprint of its contaminant testing platform for biopharmaceutical and vaccine manufacturing and for new product development.
Medical device companies are seeking to reduce product defects and increase patient safety with an industry-managed program that focuses on final product quality via oversight of the most critical manufacturing processes. Modeled on a 30-year-old aerospace industry program called Nadcap, Medaccred brings device manufacturers and suppliers together to define accreditation for special processes.