News
Your source for the latest updates, breakthroughs, and insights in drug development and manufacturing. Explore our featured stories, press releases, and event announcements to stay informed about our innovations and contributions to drug development and manufacturing advancements.
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 [...]
Avance Biosciences™ Completes Successful FDA Inspection
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. [...]
Avance Biosciences™ Signed MSA
In the week of March 18, 2012, Avance Biosciences™ entered a Master Service Agreement (MSA) with a global leader in custom biologics manufacturing. Based on this agreement, Avance Biosciences™ will provide its GMP level Cell Bank Characterization services, including DNA Sequencing, qPCR, Southern blot and other molecular biological methods, to characterize the Master Cell Bank (MCB), Working Cell Bank (WCB), and End of Production Cells (EOPC) submitted by the clients.