GMP– tag –
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Orca Bio Expands East Coast Manufacturing Capacity and Triples West Coast Workforce Ahead of Potential Orca-T® Commercial Launch, with FDA PDUFA Date Set for July 6, 2026
Business Wire USA Overview Orca Bio announced significant manufacturing expansions for its investigational cell therapy, Orca-T®, in anticipation of its commercial launch. This includes establishing new East Coast manufacturing capacity ... -
Cell Therapy Weekly: uniQure Plans BLA Submission for Huntington’s Gene Therapy AMT-130; Ernexa Prepares IND for iMSC, Autolus Reports Early Phase I Data for SLE CAR-T
Cell & Gene Therapy Insights USA Overview uniQure plans to submit a Biologics License Application (BLA) for AMT-130, a gene therapy for Huntington's disease, in Q3 2026, based on three-year Phase I/II data. Ernexa Therapeutics has comple... -
Cellares Secures $327M in Series D Funding, Including ARK Invest, and Expands Major Manufacturing Agreements with Bristol Myers Squibb and Cabaletta Bio
AllSci USA Overview Cellares has extended its Series D financing to $327 million with a new $50 million investment, specifically aimed at scaling cell therapy manufacturing. As an Integrated Development and Manufacturing Organization (ID... -
Biotech M&A in 2026: Manufacturing Complexity and Cost Remain Key Constraints to Commercial Scalability
Financier Worldwide UK Overview Despite accelerating M&A activity in biotech and life sciences in 2026, experts indicate that the manufacturing complexity and high costs of cell and gene therapies continue to limit commercial scalabi... -
Minaris Strengthens Philadelphia GMP Facility, Integrating Cell & Gene Therapy Manufacturing and Testing to Streamline Production
BriefGlance.com USA Overview Minaris, a leading CDMO, has significantly upgraded its GMP cell banking suite at its Philadelphia facility, aiming to streamline cell and gene therapy production. This expansion integrates manufacturing and ... -
Made Scientific and Pluristyx Form Strategic Partnership to Integrate iPSC Technology and Expand Cell Therapy Manufacturing CDMO Services
BioPharm International USA Overview Made Scientific announced a strategic partnership with Pluristyx, an iPSC technology platform provider, to integrate iPSC technology into its cell therapy CDMO services. This collaboration will provide... -
Fujifilm Reshuffles Life Sciences Leadership and Opens New Facility to Quadruple iPSC Manufacturing Capacity
FUJIFILM Holdings America Corporation Press Release USA Overview FUJIFILM Holdings America Corporation announced a reshuffle in the leadership of its life sciences group, with Delara Motlagh appointed as President and COO of FUJIFILM Cel... -
Avaí Bio Achieves GMP Milestone for Anti-Aging Cell Therapy; Beam Therapeutics Targets Accelerated Approval for BEAM-302; Sana Partners with Mayo Clinic for Type 1 Diabetes
Newswire.ca Canada Overview Multiple biotech companies reported significant advancements: Avaí Bio completed its GMP-grade Master Cell Bank (MCB) for the α-Klotho anti-aging program, paving the way for preclinical and clinical trials. Be... -
Made Scientific and Pluristyx Announce Integrated iPSC Development & Manufacturing Partnership to Accelerate Next-Generation iPSC-Derived Cell Therapies
PR Newswire USA Overview Made Scientific, a cell therapy CDMO, and Pluristyx, an iPSC platform technology provider, announced an integrated iPSC development and manufacturing partnership. This collaboration aims to accelerate the clinica... -
Avaí Bio Establishes GMP-Grade Master Cell Bank for Alpha-Klotho Anti-Aging Program, Advancing Cell Therapy Toward Commercialization
PR Newswire (via USA News Group) USA Overview Avaí Bio has achieved a critical manufacturing milestone by completing its GMP-grade Master Cell Bank (MCB) for the alpha-Klotho anti-aging program. This MCB ensures a high-quality, standardi...
