The United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM)...
ZURICH (Reuters) - Swiss drugmaker Novartis (NOVN.S) boosted its 2019 forecasts on Tuesday after beating third-quarter expectations, a feat helped by the sales debut of gene therapy Zolgensma, the world’s most expensive one-time treatment. CEO Vas Narasimhan’s bet on the potential cure for spinal muscular atrophy (SMA) has drawn scrutiny, initially due to its [...]
From City of Hope by Letisia Marquez The first CAR T cell therapy targeting the B cell-activating factor receptor on cancerous cells eradicated CD19-targeted therapy-resistant human leukemia and lymphoma cells in animal models, according to City of Hope research published today in Science Translational Medicine. The new therapy will be used in [...]
Avance offers CAR T-Cell therapy testing services supporting drug development and manufacturing. Avance Biosciences provides the development, validation and testing services for assays required by regulatory agencies for thorough characterization of manufactured CAR T-cells, and routine monitoring of modified T-cells levels in patients’ blood during the clinical trial or patient treatment phase...
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 [...]
Chimeric Antigen Receptor T-cell Therapy, CAR-T, is a type of cancer immunotherapy that has gained world-wide interest in recent years, especially after FDA approval of CAR-T treatments for B-cell acute lymphoblastic leukemia and large B-cell non-Hodgkin’s lymphoma. CAR-T therapy utilizes a genetic modification of a patient’s T-cells to express a target that is specific for [...]
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 well as various analyses performed [...]
Digital PCR (dPCR) provides precise and absolute quantification of nucleic acids without a standard curve and without dependence on amplification efficiency.Digital PCR is ultrasensitive; therefore, appropriate for testing allelic variants and targets of low abundance that are below the sensitivity limit of QPCR. It is also very precise, and is a better tool than QPCR when precise determination of the ratio of several nucleic acid sequences is required.
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.