We work collaboratively with clients as a cross-functional disciplinary team, ensuring projects are completed on time, on budget, and successfully progress through the regulatory pathway. While working with InfinixBio, you will be involved in every step of the way.

Clinical

Pharmacokinetic (PK) Analysis

InfinixBio understands that when it comes to PK, ADME assays, PD assessments, and DMPK assays, it is critical that the bioanalytical method is well-characterized and fully validated. All pharmacokinetic studies are performed with strict compliance with the FDA’s GLP guidelines.

InfinixBio develops and validates Non-GLP/GLP PK Bioanalysis with partial or fully validated LC-MS/MS or ELISA-based assays to screen clinical trial samples.

pharmacokinetic

Toxicological Support

Toxicokinetic (TK) analysis services for dose range finding, single and repeated dose toxicological study.

toxicological

Immunogenicity Testing (ADA Analysis)

InfinixBio can conduct the full spectrum of ADA studies, including Screening, Confirmation Assays, and Titration Assays.

InfinixBio can perform full spectrum of ADA screening and analysis for biological test article in matrix. Rapid ADA assay development and validation for biologic molecules. IgG and IgM screening, confirmation and titration assays are developed based on CutPoint determination.

Immunogenicity

Gene Therapy Immunogenicity

AAV-vector-based gene therapy activates a diverse set of immune responses. InfinixBio provides comprehensive bioanalytical strategies and approaches for all AAV serotypes to all types of immunogenicity covering the innate, humoral & cellular responses. We can also perform a product risk assessment in the host.

Therapy Immunogenicity

Biomarker Testing Services

GLP/Non-GLP method development, validation of large and small molecule bioanalysis. Assay development, ELISA, Luminex, FACS, qPCR, Western Blot and commercial assay kits.

Biomarker

Reaching your goals is our mission