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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 [...]
FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic
The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and [...]
Avance Biosciences™ Recognized as Top 10 Genomics Solutions Company
Pharm Tech Outlook, a highly respected pharmaceutical/biotech industry magazine, has recognized Avance Biosciences™ as a top 10 Genomics Solutions Company for 2020. Genomic technologies and their usage have seen extensive growth in the [...]