The number of cell and gene therapy (CGT) products in development and clinical trials continues to increase exponentially. To meet the growing demands of CGT development, SBH Sciences utilizes highly sensitive and accurate state-of-the-art instruments such as the fully automatic ELISA workstation, Jess, Flow Cytometry, Luminex, ELLA, and qRT-PCR.
CGT bioanalytical methods frequently measure an analyte that occurs as a breakdown / downstream product of the original / administered therapeutic. Both CGT and biomarker assays often lack a true reference material. This necessitates the testing of the original therapeutic product, the breakdown product, and the endogenous proteins.
We measure the presence of neutralizing antibodies (NAb) against gene therapy vectors (e.g., anti-AAV). As a positive control, we are using purified antibodies and positive sera from human subjects known to be positive. We are also assisting clients by testing animal samples such as pig serum.
