On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell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 The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors [...]
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 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]
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 Administration in Oct 2018, is undergoing major expansion to handle rapidly growing demand for their services. [...]
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 Cosmetic Act as enabling statutes for oversight. Cellular therapy products include cellular immunotherapies, cancer vaccines, [...]
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 past decade. Over the years, these technologies have evolved significantly and can now be used [...]
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). Comparing blood samples from patients with gliomas with tumor biopsy tissues from the same patients, [...]
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 deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to [...]
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 bacteria1, basically bacterial predators. One hundred times smaller than a bacterium, phage are found wherever [...]
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 will improve many aspects of scientific research and advance the field of personalized medicine. Because [...]
HOUSTON, Oct. 30, 2018 - Avance Biosciences™, Inc., a leading biological testing company supporting drug development and manufacturing, announced today that its Houston facility was inspected by the U.S. Food and Drug Administration on October 01 through October 04, 2018. This inspection focused on the firm’s quality management system, operation procedures, and data integrity, as [...]
