Catalent made a series of deals early this decade to build up its presence in Gosselies. Now, it's planning to wind down cell ...
To evaluate the potential for applying GMP-ready robotic systems to commercial-scale cell therapy manufacturing.
Multiply Labs' goal is to enable scalable, high-throughput manufacturing while maintaining rigorous quality and regulatory standards.
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
Raw materials play a critical role in cell therapy manufacturing. Choosing suboptimal materials at any stage of development ...
Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after inking a long-term lease for manufacturing and office space in the Netherlands.
The first half of 2025 has been a notable one for Cellares. The cell therapy manufacturer operates its first commercial-scale Integrated Development and Manufacturing Organization Smart Factory in ...
To thrive beyond rare disease, cell and gene therapy developers must scale-up manufacturing and commercialisation.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.
Reducing manual touchpoints is an important part of supporting more consistent and scalable manufacturing processes.
Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration has granted orphan drug ...