Gene Therapy & Cell Therapy

Our experience in gene therapy bioanalysis spans in vivo and ex vivo studies, with specialized expertise developing robust and novel bioanalytical methods to understand the distribution, function, efficacy, and immunogenicity of innovative gene therapeutic candidates in line with regulatory requirements. We have also been successfully supporting cell therapy programs involving TIL, TCR, CAR, and other innovative modalities across a variety of delivery mechanisms and matrices for over 10 years. BioAgilytix is additionally experienced in developing bioanalytical strategies to investigate the mechanisms of oncolytic virus immunotherapies, from their antitumor properties to immune interaction effects.

We are able to offer deep GxP regulatory knowledge and proven capabilities to support these studies from preclinical phases through clinical trials and post-marketing surveillance. We leverage comprehensive expertise, a state-of-the-art platform suite, and a proven regulatory track record to efficiently progress your gene therapy or cell therapy through all phases of development – tailoring our bioanalytical package to your unique study requirements.