Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
Increasingly, pharmaceutical manufacturers are transitioning to continuous monitoring systems powered by AI, where compliance is assessed in real time throughout the production lifecycle rather than ...
Overcoming common challenges with today’s biologics, such as developing devices for high-concentration subcutaneous ...
The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’s request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex ...
Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...
(RTTNews) - Vericel Corporation (VCEL) announced that the U.S. FDA has approved commercial manufacturing of MACI at its new state-of-the-art cell therapy facility in Burlington, Massachusetts. The ...
Beginning January 1, 2026, the company's collagen production will operate out of MPM Medical's 100,000 sq. ft. FDA-registered facility in Mesquite, Texas. The expansion includes advanced collagen ...
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