The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
News|Articles|May 4, 2016
MilliporeSigma Expands California GMP Facility
Author(s)Pharmaceutical Technology Editors
MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.
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MilliporeSigma is expanding its Carlsbad, California facility to meet growing demand for viral and gene-therapy products, the company announced on May 4, 2016. The facility will increase from 44,000 to 65,000 ft2, with 16 modular, viral bulk manufacturing cleanroom suites, two fill/finish suites, and twice the warehouse capacity. The expansion will incorporate single-use equipment in a flexible, scalable format for clinical and commercial bulk drug production.
The company's new capacity at Carlsbad positions MilliporeSigma to support customers from clinical to commercial scales and is complemented by cell-banking services in Rockville, Maryland; viral and gene-therapy manufacturing capacity in Glasgow, Scotland; and global BioReliance biosafety testing offering.
The Carlsbad facility’s segregated fill/finish capacity for gene therapy, viral vaccine, and immunotherapy products will remain fully operational throughout the expansion, which is scheduled for completion in 2016.
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