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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 [...]
MASS General researchers show ddPCR brain tumor liquid biopsy assay has tenfold improvement in sensitivity over any prior assay
Genetic mutations that promote the growth of the most common type of adult brain tumors can be accurately detected and monitored in blood samples using an enhanced form of liquid biopsy developed by researchers at Harvard-affiliated Massachusetts General Hospital (MGH). [...]
FDA approves first liquid biopsy next-generation sequencing companion diagnostic test
Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a [...]
Phage Testing of Bacterial Cultures
Regulatory agencies require companies using microbial cell lines that produce products for human use to regularly complete biosafety testing to ensure that cell banks are free of phage contamination. Bacteriophage (phage) is a virus that infects and replicates within [...]
NGS for Biologics Development Support
NGS represents a technological leap that has potential to revolutionize drug discovery and development. Next Generation Sequencing (NGS) has the potential to unlock causative factors from our genetic material. NGS also represents a technological advancement using array-based sequencing that [...]