From discovery through Phases I, II, III and IV, BioAgilytix offers fully integrated bioanalytical laboratory services to support every stage of biologics development. We are a specialized GLP and GMP compliant bioanalytical lab offering a unique combination of veteran expertise, premier lab facilities, and deep regulatory know-how, which we fully leverage in helping our customers compress their timeline from discovery to market.
Working scientist to scientist, we are able to efficiently solve complex bioanalytical challenges—while exceeding quality expectations all along the way.
BioAgilytix is specialized in large molecule bioanalysis, but broad in our capabilities to support biomarkers, immunogenicity & pharmacokinetics (PK), and cell-based assays. Our state-of-the-art bioanalytical lab features a broad range of innovative platforms which we leverage with these assays to optimize accuracy, reproducibility, and time to results.
Our specialized large molecule focus enables us to take on complex and demanding project requirements. No matter where your project is in the bioanalytical lifecycle, or the level of difficulty it represents, BioAgilytix’s scientific experts are up to the challenge to provide high-quality results.
Assay Development Services
This scientifically demanding area is where BioAgilytix excels, collaborating alongside your internal team to characterize your novel compounds to support rapid decision making on next steps. Our custom assay development services leverage the extensive and robust method development expertise of our scientists to design unique solutions optimized to your needs.
To confirm an assay’s precision, accuracy, and ruggedness under a range of conditions, BioAgilytix will evaluate and verify that its performance consistently meets quality and compliance standards.
Leveraging the comprehensive platform suite within our bioanalytical lab, we help customers realize the benefits of greater throughput, better reproducibility, and high analysis accuracy. We are capable of rapidly delivering high-quality, reliable results for studies at every preclinical and clinical phase.
Lot Release Testing for Manufacturing
As a GLP and GMP bioanalytical lab facility, BioAgilytix supports product releases of biologics, biosimilars, and biobetters including optimization of assays in support of process improvement and measurement of peptides, proteins, and monoclonal antibodies in the presence of various formulations and excipients.
Your work doesn’t end at product launch and neither do our bioanalytical laboratory services. We provide post-market surveillance with ongoing data gathering and sample analysis from broader market populations to ensure continued quality and compliance.
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Our scientific team averages 15+ years of bench experience, working firsthand in the bioanalytical lab to hone their cell-based assay and immunoassay expertise. In fact, over half are PhD and Masters-level scientists. We have seen and know the types of challenges to anticipate in each phase, and work proactively to mitigate your risk by solving problems before they become larger obstacles that adversely affect costs and timelines.
It is because of our veteran skill that we can offer a uniquely collaborative experience to customers who engage our bioanalytical laboratory services. Our approach to problem solving is founded on partnership with internal scientific teams, working hand-in-hand to overcome assay complexities. Whether we are supporting novel pharmaceutical drugs or scientific breakthroughs in agriculture and animal health, the BioAgilytix team shares your commitment and sense of urgency to quickly progress your innovation.
See the results that quality science delivers with BioAgilytix as your bioanalytical lab partner.