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UMass Chan researchers describe innovative next-gen sequencing technique for evaluating manufacture of vectors for gene therapy
A paper from the Horae Gene Therapy Center at UMass Chan Medical School may settle a longstanding debate about how to best manufacture adeno-associated virus (AAV) vectors for gene therapy. The paper, published online in the journal Human Gene Therapy, describes [...]
FDA issues new draft guidelines on genome editing and CAR-T therapy
On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, [...]
Avance Biosciences™ Announces Validation of New Facilities, Expansion of Mammalian Cell Culture and Protein Analysis Services
HOUSTON, May 5, 2022 /PRNewswire/ -- Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today completion of move-in and validation of an additional 26,000 square feet [...]
FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients
Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 [...]
Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences™ for Cell-Based Therapies
GMP-compliant test for transduction efficiency marks a key milestone for Tapestri’s ability to power single-cell analysis in clinical trial settings for cell & gene therapies SOUTH SAN FRANCISCO, February 2, 2021 -- Mission Bio, the pioneer in high-throughput single-cell [...]
Avance Biosciences™ Expanding Houston Campus
HOUSTON, Feb. 16, 2021 /PRNewswire/ -- Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today that its Houston facility, which successfully passed an inspection by the U.S. Food and Drug [...]