The InfinixBio team is a diverse and accomplished group of scientists, working collaboratively with the client to ensure projects are completed efficiently, on time and on budget. You can trust that our expert scientists will deliver high quality results.

Pre-Clinical

Pharmacokinetic (PK) Analysis

When it comes to gene therapy immunogenicity, InfinixBio stands at the forefront, offering solutions that are second to none. Our services encompass ADME assays, PD assessments, and DMPK assays, all conducted with meticulous attention to detail and in compliance with the FDA's GLP guidelines. Our expertise extends to toxicology support and animal model selection, ensuring a holistic approach to drug development.

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Toxicological Support

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

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Animal Model Selection

Choosing the correct animal model for pharmaceutical research is essential for obtaining accurate results. InfinixBio’s animal selection model can save time and money and increase the likelihood of success during the preclinical phase of your research.

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Immunogenicity Testing (ADA Analysis)

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.

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Gene Therapy Immunogenicity

InfinixBio specializes in gene therapy immunogenicity, particularly in the context of AAV-vector-based therapies. PK analysis and toxicology support play pivotal roles in comprehending the immune responses triggered by gene therapy, ensuring treatment success. Our experts offer bioanalytical strategies for all AAV serotypes, covering various types of immunogenicity, including innate, humoral, and cellular responses.

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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.

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Support for 510(k) and LDT Approval

InfinixBio designs and conducts studies to support both 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests.

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We take your investment to the next level