Press Kit

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.

BioAgilytix is singularly committed to providing you with the scientific and regulatory expertise needed to overcome bioanalytical complexities and avoid quality pitfalls in every phase of development. Put your large molecule therapeutics in our expert hands, and we will give you the confidence of the most accurate, precise, and comprehensive high-quality scientific processes and data – with results that are delivered right on time, and right the first time.

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FAQ

BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across several industries and disease states.

BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.

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
  • Cell Therapy
  • Vaccine assays
  • Immuno-oncology
  • Antibody drug conjugates (ADCs)
  • Toxicology studies
  • Gene therapy
  • 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

BioAgilytix corporate headquarters in Durham, NC boasts a 89,109 square foot, high-capacity facility with an upcoming addition of a second campus bringing the total square footage to ~265,000. Located in the Research Triangle Park region, 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.

The BioAgilytix San Diego facility has 34,000 square feet of office and laboratory space which includes sample preparation laboratories, an immunoassay laboratory, and mass spectrometry laboratories. The laboratories are equipped with lights that prevent degradation of photosensitive drugs, and the facility is secured by an alarm system, a surveillance camera system, and a badge access system. We also have an additional 2,000 square feet of offsite archive space in San Diego.

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.

BioAgilytix Australian headquarters in Melbourne are located within the world-renowned Burnet Institute at the Alfred Hospital biomedical and clinical research precinct, also home to Australia’s largest Phase 1 unit.  The Melbourne laboratory facilities are perfectly situated to benefit from the unique advantages of conducting studies in Australia and boosts 29,800 square feet of laboratory space.

BioAgilytix’s Brisbane laboratory is located in the Translational Research Institute (TRI). Co-located with the TRI Clinical Research Facility (CRF) at the Princess Alexandra Hospital (PAH) the facility provides state-of-the-art specialist facilities, resources and expertise for investigator led and commercially sponsored clinical trials and has 16,800 square feet of laboratory space.

$125 – 200 million

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