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Successful Proprietary Drug Development Company turns to InfinixBio for Pre-clinical All-In-One Studies and Bioanalysis

After successfully developing a proprietary drug that had shown efficacy in mice, this biotechnology company turned to InfinixBio for help with preclinical bioanalysis assays and toxicology studies.

The company’s proprietary platform for the development of innovative protein drugs utilized fusion proteins containing one or more active domains attached to a binding protein that concentrates the drug in the target tissues – practically speaking, their tech was designed to target drug delivery to the tumor microenvironment and lymphatic system with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs.

The first stage of our collaboration involved selecting the appropriate animal species for continued toxicology studies. In addition to cell-based studies determining whether different animal species were sensitive to their drug’s active domains, we performed solution and solid phase binding studies to determine whether the binding domain recognized the target proteins within different animal species.

After selecting the appropriate species for testing, we developed, validated, and performed bioanalysis assays of animal serum samples under GLP conditions and then performed the toxicokinetic analysis of these samples. InfinixBio also developed and performed Anti-Drug-Antibody (ADA) assays on samples following different dosing regimens and assisted the company with the FDA approval process.