Viral Vector– tag –
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Liv Hospital Charts Course for Scalable CAR-T Production with Comprehensive GMP and Bioreactor Guide
Liv Hospital Turkey Overview Liv Hospital has released a comprehensive guide detailing the critical, GMP-compliant manufacturing process for CAR-T cell therapies, from T-cell collection and genetic modification to controlled expansion in... -
Oxford Biomedica Launches Fast-Track Viral Vector Service, Accelerating Gene Therapy Development by Cutting Manufacturing Times by up to 8 Months
Kalkine UK Overview Oxford Biomedica has launched a fast-track viral vector service to accelerate gene therapy development. This new service shortens GMP-grade manufacturing for AAV vectors from approximately 15 months to as little as 7 ... -
Texas Children’s Hospital’s GMP Facility Manufactures Over 10,000 Cell Therapy Products in 20 Years, Driving CGT Innovation
Texas Children's Hospital USA Overview Texas Children's Hospital's Center for Cell and Gene Therapy (CAGT) has manufactured over 10,000 cell therapy products and more than 70 clinical-grade viral vectors over two decades, utilizing its i... -
Fatal Adverse Event Halts HuidaGene’s First-in-Human CRISPR Gene Therapy Trial for DMD
HuidaGene Therapeutics China Overview HuidaGene Therapeutics has reported a fatal serious adverse event (SAE) in the HG302-01 first-in-human trial of its investigational CRISPR-based gene-editing therapy, HG302, for Duchenne muscular dys... -
Merck’s sBLA for ENFLONSIA™ Accepted by FDA for Expanded RSV Prophylaxis in High-Risk Infants Under Two for Second Season
Merck.com (News releases) USA Overview Merck announced that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for ENFLONSIA™ (clesrovimab-cfor) to expand its Respiratory Syncytial Virus (RSV) lower respirato... -
FDA Grants Accelerated Approval for Oncoytic Virus Tudriqev + Nivolumab in Unresectable Advanced Melanoma
Drugs.com USA Overview The U.S. FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic virus therapy, in combination with nivolumab for the treatment of unresectable advanced c... -
FDA Grants Accelerated Approval to Replimune’s Onco-Viral Therapy Tudriqev in Combination with Nivolumab for Advanced Melanoma, Offering New Treatment Option
U.S. Food and Drug Administration USA Overview The U.S. FDA granted accelerated approval to Replimune, Inc.'s oncolytic viral therapy Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adult patients with advance... -
PTC Therapeutics and Eli Lilly to Acquire Sangamo Assets for Up to $264M in Bankruptcy Auction, Bolstering Rare Disease Pipelines
Endpoints News USA Overview PTC Therapeutics and Eli Lilly are set to acquire parts of the bankrupt gene editing biotech Sangamo for up to $264 million following an auction. PTC Therapeutics will acquire Sangamo's Fabry disease candidate... -
Merck Expands Singapore BioReliance Lab with Asia Pacific’s First Cell Line Characterization and GMP NGS Capabilities
BioPharma APAC Singapore Overview Merck is expanding its Singapore BioReliance lab to strengthen analytical and biosafety testing services in the Asia Pacific region. The expanded facility will offer the first BioReliance Cell Line Chara... -
Porton Advanced Secures China NMPA Drug License to Expand CDMO Services to Commercial CGT Manufacturing
Porton Advanced China Overview Porton Advanced has been granted a Class C Drug Manufacturing License by China's NMPA, enabling it to undertake commercial contract manufacturing for Cell and Gene Therapy (CGT) products. This expands their...
