Cell Therapy Products Bioanalysis

What is the Role of CAR-T Cell Therapies in the Market Today?

Immunotherapy empowers a patient’s own immune system to locate and destroy cancer cells. Chimeric antigen receptor T-cell therapy (or CAR T therapy) is the latest and most exciting anti-cancer therapy to make the news, with the FDA recently approving significant treatment breakthroughs in the form of CAR T-cell therapies: one to treat certain pediatric and young adult patients with acute lymphoblastic leukemia and another for diffuse large B cell lymphoma. Both treatments mark important milestones in cancer therapy.

CAR T-cell therapy involves the collection and genetic modification of T-cells in order to introduce a new gene that allows the CAR T-cells to target and kill the patient’s cancer cells. T-cells are extracted from the patient and modified via various methods (CRISPR, Replication deficient Lenti- and Retro-viruses) to introduce the engineered receptor into the cells. This gene is then incorporated into the nucleic DNA of the patient’s T-cells resulting in a “chimeric” T-cell, having the cellular immune functions of the host T-cells, but engineered to readily recognize and kill cancer cells. These chimeric T-cells are cultured and expanded to obtain the drug product for the patient. These cells are then transfused back into the patient where the CAR-T cells seek and destroy the cancerous cells, usually within 2-4 weeks.

The results from clinical trials utilizing CAR-T are promising, as they show a very effective and efficient treatment with less severe side effects than those associated with chemo- or radiation therapy. Another advantage of CAR-T cell therapy is that this therapeutic can develop into dormant memory T-cells that will monitor the patient for possible relapse of the same cancer. Should relapse occur, the CAR T-cells become active again and proceed to destroy the reoccurring cancer cells.

How does BioAgilytix Perform its CAR T Related Services?

Ensuring the safety and efficacy of CAR T therapeutics, especially because a retrovirus is used during their production, is critical. BioAgilytix has a long history of expertise in immunology and oncology, and as such has been a partner of choice to those in the industry that are making significant strides in CAR T-cell cancer treatments.

For over 10 years, we have been successfully supporting development programs involving CAR and other innovative modalities for cell therapies across a variety of delivery mechanisms and matrices. Through the collective services and resources available at our US laboratory locations in Boston, MA and Durham, NC and our European lab in Hamburg, Germany, we are able to offer deep GxP regulatory knowledge and proven qPCR, flow cytometry, and immunoassay capabilities to support your CAR T therapy program from preclinical phases through clinical trials and post-marketing surveillance.

How will BioAgilytix Support my CAR T cell Therapy Program?

Extremely promising advances in science and medicine now exist where none were available previously. There is much more to discover in the years ahead to as a bona fide treatment of blood cancers and, hopefully, other forms of cancer as well. The BioAgilytix team is dedicated to specializing in this novel cancer therapy to provide the data necessary to advance this important research.Our teams in Boston, North Carolina, and Hamburg – all of which average over 10 years of bench experience and are comprised of over 50% Ph.D. and Masters-level scientists – are ready to help you explore new ways to utilize CAR T therapy to bring new treatment options to oncology patients.

What Types of Assessments for CAR T therapies does BioAgilytix Offer?

CAR T therapy is a novel approach to cancer treatment and therefore requires novel methods to monitor and quantify the progression and effects of the therapeutic. It needs to be characterized by immunophenotyping, usually by flow cytometry, and tested for the presence of the T-cell receptor gene, routinely performed using qPCR. Monitoring the possibility of reversion of the replication deficient retroviruses is also needed during production and treatment and can be monitored using RT-PCR and cell-based assays.

Patient symptoms must be monitored carefully during the 2-4 weeks post infusion to ensure that any serious side effects can be mitigated, and immunoassays (via ELISA, MSD, Luminex, etc.) are used to measure cytokines and potential anti-therapeutic antibodies generated by the patient’s immune system. Long term follow-up of the patient also involves monitoring the persistence of the CAR T-cells in the memory compartment of the cellular immune system. These can be detected by qPCR or cell-based proliferation assays.

BioAgiytix pairs our unique, highly specialized scientific capabilities with cutting-edge platforms to ensure delivery of reliable, timely, high-quality results from these range of assessments including: