Cell and Gene Therapies (CGTs) are types of treatment that uses cellular or genetic material with the goal of treating a disease or a disordered. Often it can be a combination of cell and gene therapies, which is the case for Chimeric antigen receptor T cells (CAR T-Cells). As of March 2022, there are 20 FDA approved CGT licensed products from the Office of Tissues and Advanced Therapies (OTAT) and according to clinicaltrials.gov over 2,000 active CGT clinical trials. The Age of Cell & Gene Therapy is upon us!
There are two critical questions customers are coming to KCAS and asking for support of CTGs. Can you help with development of a bioanalytical PK/PD method? How and what sample should I collect for support of my clinical trials. With over 40+ years of PK/PD bionalaysis experience and decades of stabilization of samples and clinical kitting & supplies we have the solutions. You can find answers and information about CGT sample logistics (click here to read our blog last month specifically addressing “Clinical Support and Kitting (CSK) Drug Development Solutions for Support of Cell & Gene Therapies”).
As the age of CTGs is upon us, the demand for PK/PD and Immunogenicity bioanalytical method development and qualification/validation has exploded. KCAS in early 2022 brought on quantitative PCR, digital drop PCR (ddPCR), and ELISPOT technologies. With these additions below are the types of bioanalytical services that KCAS now offer for support of pre-clinical and clinical trials:
- Pharmacokinetics (PK) – qPCR, ddPCR, Flow cytometry, LBA assays
- Biodistribution – qPCR, ddPCR, Flow cytometry, LBA assays
- Immunogenicity – LBA assays, Flow cytometry Cell-based assays (Nab); against transgene, viral vectors, etc.
- Pharmacodynamic Markers – qPCR, ddPCR, Flow Cytometry, ELISPOT, LBA assays
- Viral Shedding (Outcomes and Safety) – ddPCR, qPCR, cell-based infectivity assays
- Molecular Capabilities for all Types of Discovery Projects
Whether you are working on cell therapies, gene therapies, or a combination of cell and gene therapies KCAS has you covered. As we are settling into our built for purpose 70,000 sq/ft facility and having acquired Flowmetric in Jan of 2022 we are poised to be a global leader for support of CTGs. If you have questions related to bioanalysis of CGTs we are the partner for you.
If you’d like to hear more about our Hybrid capabilities, please contact KCAS using the form below.