Chimeric Antigen Receptor Modified T-cell Therapy, CAR T-cell therapy, is a type of cancer immunotherapy that has gained world-wide interest in recent years, especially after FDA approval of CAR T-cell therapy for B-cell acute lymphoblastic leukemia and large B-cell non-Hodgkin’s lymphoma. To ensure the safety of the CAR T-cell therapy, 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.
Cell Therapy Testing Services
Copy Number Analysis
for CAR T-cells
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.
qPCR for Preclinical
Biodistribution Study
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.
Integration Site
Analysis
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.
Replication Competent
Lentivirus (RCL) Assay for CAR T-cells
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 assay services using qPCR and ddPCR methods.
Testing of RNAs in Animal Tissues and Human Blood
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.
All Avance Biosciences™ Services Include
- Methods validated per ICH GLP/GMP guidelines – also research grade testing available
- Independent quality unit assuring regulatory compliance
- Experienced scientists functioning as project managers or study directors
- Controlled laboratory environment to prevent cross-contamination
Choose Avance Biosciences™ as your trusted partner in CAR T-Cell Therapy Testing, ensuring the safety and efficacy of modified T-cells and compliance with evolving regulatory standards.
Our Customers Say…
Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.
Head of Quality Control, Microbial Manufacturing Service, California
Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.
Bioanalytical Senior Project Manager, California
My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.
Director Individualized Medicines, California
Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.
Senior Director, Cell & Gene Therapy Business, California
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Extensive Experience
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.
Open Communication
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Cutting Edge Science
Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.