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About Us

BioAgilytix’s global team of highly experienced scientific and QA professionals deliver world-leading science, proven data integrity, and deep regulatory expertise to support all phases of large molecule global studies. Today we provide comprehensive GxP services to innovators all over the world, including many of the top global pharmaceutical and biotech companies.

Our cutting edge bioanalytical lab has evolved the model for partnership in large molecule bioanalysis to benefit our customers and the patients they serve. Don’t allow a promising drug candidate or clinical study to stall out due to a lack of expertise or resources. BioAgilytix provides best-in-class bioanalytical capabilities that are needed to address the most challenging biomarker, immunogenicity, PK and cell-based assay requirements.

In an ever-changing world, the need for complex clinical problem solving is a necessity. BioAgilytix is the gold standard in large molecule bioanalysis. Our passion for science drives our ability to deliver premium services 100% of the time.




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Company Fact Sheet



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BioAgilytix is a global contract research organization (CRO) that specializes in large molecule needs, enabling scientific innovators to develop and deliver game-changing biologic innovations through our expertise in cell-based assays, biomarkers, immunogenicity and pharmacokinetics (PK).

Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market.

As the number of biologics and biosimilars entering drug development programs continues to increase, so does the need for more robust and sensitive assays that can precisely measure their activity and potency. These assays require a CRO lab partner with both scientific and regulatory know-how.

We employ real-world, veteran insight to help our customers successfully navigate the inherent complexities of large molecule bioanalysis, for both scientific and regulatory demands. Our assay focus and list of services include, but is not limited to:

  • Assay development
  • Assay validation
  • Sample analysis
  • Biomarkers
  • Biosimilar testing services
  • Immunogenicity
  • Pharmacokinetics (PK) and pharmacodynamics (PD)
  • Cell-based assays
  • CAR T-Cell therapy
  • Vaccine assays
  • Immuno-oncology
  • Antibody drug conjugates (ADCs)
  • Toxicology studies
  • Gene therapy development
  • Critical reagents
  • COVID-19 testing for clinical trials
  • Lot release testing
  • Post-marketing surveillance

BioAgilytix currently has six locations

  • USA Headquarters in Durham, NC
  • European Headquarters in Hamburg, Germany
  • Laboratories in Boston, MA; San Diego, CA; and Melbourne and Brisbane, Australia

Dr. Afshin Safavi, Ph.D. and Matt Langevin, MS, co-founded BioAgilytix in 2008 with a small team of 10 employees in Durham, NC.

BioAgilytix boasts a 78,685 square foot, high-capacity facility. Located in the Research Triangle Park region of Durham, NC, USA, this world-class research facility has the capacity to support discovery, preclinical, clinical and manufacturing trial phases.

The BioAgilytix Boston location is a 26,453 square foot laboratory located in the heart of the world’s biotech innovation hub and boasts a 20-plus-year track record of delivering premier bioanalytical services along with specialized diagnostic testing.

BioAgilytix’s EU headquarters in Hamburg, Germany is home to a state-of-the-art lab, at 29,902 square feet in size and is one of the most technologically advanced bioanalytical laboratories in Europe. This research lab is devoted to assay development and validation, sample analysis, lot release testing and biomarker services to support global disease studies.


$125 – 200 million

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