CAR-T and Other Cell Therapy TestingChris Hebel2019-05-09T11:33:27+00:00
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. To ensure the safety of the CAR-T treatment, regulatory agencies require thorough characterization of the manufactured CAR T-Cells. In addition, during the clinical trial or patient treatment phase, the level of modified T-cells in patients’ blood must be monitored frequently in a timely manner.
Regulatory agencies require CAR-T sponsors to determine the copy number of the inserted genes in manufactured CAR-T cells before releasing for patient treatment. Avance Biosciences’ team has more than two decades of experience in designing and validating qPCR copy number assays, and executed hundreds of copy number analysis projects in compliance with cGMP regulations.
in vivo toxicity studies, and sometimes shedding study, are required by regulatory agencies to evaluate the safety of therapeutic cells. Avance Biosciences offers GLP compliant qPCR, ddPCR, and NGS amplicon sequencing services to accurately assess the quantity of therapeutic cells in animal blood, CFS, and tissues for biodistribution studies.
Avance Biosciences can help our clients to design and execute custom assays to determine gene insertion sites. We use a combination of NGS, PCR, and Sanger sequencing methods to delineate and validate potential insertion junctions and their locations in host genome.
Lentivirus is commonly used to generate CAR-T cells due to its ability to insert genes into host genome. It is critical to ensure that there is no replication competent lentivirus (RCL) in the therapeutic cells. Avance Biosciences provides fast turn-around RCL testing services using qPCR and ddPCR methods.
Avance Biosciences is experienced in supporting our clients for pharmacokinetics study of mRNA or miRNA in animal tissues and in human blood. Our study directors and lab analysts are proficient in qPCR and ddPCR assay design and validation, for both relative and absolute quantification of RNAs.
We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.
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The Avance Biosciences team is committed to strict adherence to cGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
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Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.