Our relentless dedication to accuracy, timeliness and regulatory rigor enables your therapeutic innovations to reach patients faster.  We’ve succeeded in delivering many life-saving therapeutics on-time and in scope. These therapeutics have earned market approval, with bioanalytical testing provided by BioAgilytix.

Patients Are People

The better we do our job, the faster you can help patients in need. We’ve succeeded in delivering many life-saving therapeutics on-time and in-scope. These therapeutics have earned FDA approval, with assay samples validated by BioAgilytix in under 2 months.

How We Work

Services Delivered Scientist To Scientist

Our fully integrated GxP services are driven by your assay requirements and delivered by our veteran scientists – collaboratively, accurately, and on-time.

Meet Our Scientists

Solutions Enabled by Globally Recognized Experts

Our team is comprised of industry leaders who bring innovation to the complex and evolving landscape of biotherapeutics.

Advanced Bioanalytical Lab Facilities To Support All Phases Of Drug Development.

BioAgilytix has locations in three of the leading biotech and pharmaceutical areas in the United States. Our headquarters is located in the Research Triangle Park area of North Carolina where we combine specialized expertise, state-of-the-art technology, and deep regulatory knowledge to provide high-quality immunoassay support. Our second location in Boston is located in the heart of the world’s biotech innovation hub and boasts a 20-plus-year track record of delivering premier bioanalytical services with specialized diagnostic testing. Our third US location in the Sorrento Valley area of San Diego also boasts over two decades of experience in supporting DMPK, bioanalysis, and pharmacokinetic analysis.

BioAgilytix’s advanced laboratory facilities in Hamburg, Germany, serve as our European headquarters, offering a breadth and depth of services, technology, and expertise specifically for large molecule bioanalysis.

BioAgilytix has two locations within Australia. Our Melbourne laboratory is located in Australia’s biomedical and clinical research hub and is co-located with the world-class Burnet Institute, Australia’s largest Phase 1 unit, which makes us uniquely situated to support all your clinical needs. Our second facility is in Brisbane and is located in the Translational Research Institute (TRI) in Woolloongabba, whose vision is to be a global leader in the effective translation of research and innovation into improved healthcare. This focus on ‘bench to bedside’ is consistent with the BioAgilytix mission of enabling future medicines.

Science On-Demand

ADA Assessment for Cell Therapies

Cell therapies are emerging and evolving as promising therapies for a variety of disease indications. The ability to detect anti-drug antibodies (ADA) is important for patients receiving cell-based therapies. However, approaches to detecting ADAs against cell-surface biotherapeutics vary utilizing either traditional ligand binding assays or cell-based binding assays. Both ADA assay approaches have been utilized but there is no current regulatory guidance on which format is more appropriate for these therapeutics. In this presentation, we will discuss the challenges of both approaches and current industry practices.

Explore Our Resource Center

The BioAgilytix Perspective

Explore the BioAgilytix way of thinking. Visit our Resource Center to learn more about our scientists’ expertise through case studies, blogs, industry articles and other scientific resources.

Speak To A Scientist

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