Biotect Services is focused on in vitro testing of vaccine and cancer therapeutic products. Our expertise is 2D and 3D cell culture based assays to screen active ingredients for safety using different cell types.
We assist clients in developing a Target Product Profile (TPP) and characterizing the active pharmaceutical ingredient (API) to understand mechanism of action, efficacy, and safety in vitro.
In vivo studies follow to discern dosing, pharmacokinetics, pharmacodynamics and toxicity. Knowledge gained is used to support cGMP manufacturing a clinical batch and quality testing for safety, purity, efficacy, identity, potency, and sterility for use in GLP safety and toxicity studies. Results support the Investigational New Drug Application (IND) for first in human (FIH) phase 1 clinical trial.
