BeiGene Ltd.688235
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BeiGene invests $300M to expand US manufacturing, increasing capacity and mitigating tariff risks.
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Andelyn Begins Commercial Manufacturing of Ultragenyx's FDA-Approved FAYUVI Gene Therapy
Andelyn Biosciences announced it is now manufacturing FAYUVI, Ultragenyx Pharmaceutical Inc.'s FDA-approved gene therapy for Sanfilippo syndrome type A, also known as mucopolysaccharidosis type IIIA, for commercial supply at its Columbus, Ohio facility. The move follows the U.S. Food and Drug Administration's approval of FAYUVI, making it the first FDA-approved gene therapy manufactured using the Andelyn AAV Curator Platform process. Sanfilippo syndrome type A is a rare, fatal lysosomal storage disease that primarily affects the central nervous system and is marked by rapid neurodegeneration beginning in early childhood; it is estimated to affect 3,000 to 5,000 patients worldwide, with a median life expectancy of 15 years. Andelyn Chief Executive Officer Wade Macedone said the company is proud to manufacture an FDA-approved gene therapy for commercial use using an AAV Curator Platform process, calling the milestone a reflection of the purpose behind Andelyn's founding. Andelyn, a full-service FDA-inspected cell and gene therapy commercial CDMO with more than 20 years of experience, has produced clinical and commercial material for more than 500 cGMP batches and 85 global clinical trials.
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Charles River Laboratories Launches Rapid Cell Banking Platform With 40% Faster Production
Charles River Laboratories International unveiled new rapid cell banking and release programs that use advanced sequencing and in vitro tools to shorten biologics and advanced therapy cell bank lead times for biopharma clients. The platform cuts cell bank production time by 40% and combines rapid microbiological methods with NGS characterization, including the iDTECT NGS platform, to support regulatory readiness. Charles River says the approach reduces reliance on animal testing by incorporating alternative in vitro methods aligned with the 3Rs framework. The company, a US life sciences group with a market cap of about $13.1b, positions the offering for time-sensitive programs where delays are costly. Investors will watch for booked projects using the iDTECT NGS platform, client mix in advanced therapies, and whether the services appear in updated segment revenue breakdowns.