Our US Locations

Delivering Fully Integrated Biologics Services From Our Advanced GxP Labs

BioAgilytix has advanced laboratories in three locations within the hotbeds of the biopharmaceutical industry on both the East and West Coasts of the US. Our labs are located in Durham, North Carolina, which serves as our US headquarters, Boston, Massachusetts, and San Diego, California. At our locations, we combine specialized expertise, state-of-the-art technology, and deep regulatory knowledge to provide premier biologics services that accelerate small and large molecule global studies through every stage of development.
The services we offer through our US labs include development and validation of biomarkerimmunogenicitypharmacokinetics (PK), and cell-based assays to support biologic innovations. Discover why the top global pharmaceutical and biotechnology companies partner with our lab to efficiently navigate the scientific and regulatory complexities of small and large molecule bioanalytical testing.

Small And Large Molecule Capabilities Spanning Discovery To Post-Marketing Surveillance

While BioAgilytix is specialized in small and large molecule bioanalysis, we are broad in our capabilities to support the end-to-end needs of global studies for biotherapeutics development. Our US lab has the expert resources and capacity to provide assay development, assay validation, sample analysis for both large and small numbers of samples, and lot release testing services for projects spanning discovery to Phase I, II, III, and IV trials. This enables us to provide our pharmaceutical and biotechnology customers with seamless biologics services and solutions for their range of drug development requirements, and a single partner to streamline and accelerate projects that have the potential to save patient lives. Our US scientists possess leading expertise to support new advancements in gene therapyimmuno-oncologybiosimilars, and other innovative biotherapeutic solutions. We work collaboratively with internal teams to deliver science-driven bioanalytical services related to:
Biomarkers
Immunogenicity
PK/PD
Cell-Based Assays
ADC Development

Biomarkers

Our biomarker services support global studies for a range of disease states, from oncology to autoimmune, neurological, and metabolic disorders. Our Hamburg lab is able to leverage the extensive menu of over 400 biomarkers that we have developed to help streamline biotherapeutics development timelines, or can collaborate to develop and validate novel biomarker assays.

Immunogenicity

BioAgilytix’s USA lab performs immunogenicity testing to evaluate a biological product candidate’s incidence, kinetics and magnitude of anti-drug antibody (ADA), neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and the related clinical impact for patient management. Our USA team is well-versed in the complexities inherent in measuring adverse immune reactions, and works closely with our customers to develop the optimal assay strategy for their specific immunogenicity testing requirements.

Pharmacokinetics (PK)

Our European team understands the importance of PK assay data to sponsors, as it is vital to determining dosage selection for preclinical and clinical studies. They are well-versed in the factors that could influence assay data validity, and account for these realities during method validation to ensure optimal results. Our Hamburg lab has particular expertise in establishing and validating PK assays for therapeutic proteins with endogenous counterparts, and for comparative analysis of originator and biosimilar products.

Cell-Based Assays

Our European team develops and validates cell-based assays to evaluate a variety of functional and biochemical effects, including cell proliferation, apoptosis and cell death, signal transduction, enzyme activity, reporter gene activity, antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), and more.

ADC Development

Antibody drug conjugates (ADCs) provide a compelling combination of high specificity and therapeutic efficacy, representing significant opportunity for the pharmaceutical and biotechnology industries – but they are also technically challenging. BioAgilytix’s US team has leading experience in this innovative area of study, with scientists that are well-versed in conjugation strategies and the critical factors that must be considered to select the appropriate bioanalytical techniques for developing ADC solutions.

Premier Lab Facility Offering Services Under Gxp

Our recently expanded 69,000+ square foot US laboratory complies with all relevant national and international regulations and guidelines of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). We are able to tailor our services and assays to meet your required level of regulatory demands as your project progresses through the development pipeline. Our laboratories gives customers a high-capacity facility that can support an array of small and large molecule work, from preclinical phases to sample analysis for the large number of samples needed in clinical studies.

Our RTP-based lab features a broad range of innovative platforms which we leverage to optimize assay accuracy, data reproducibility, and time to results. These technologies, which we use to support global studies, include:

ELISA

MSD-ECL

Gyrolab

Flow Cytometry

LI-COR Odyssey

Luminex

Experts In Navigating The Scientific And Regulatory Complexities Of Small And Large Molecule Bioanalysis

The best science demands the best people, and our laboratories is headed by an unparalleled team of veteran BPMs, averaging 15+ years of post-schooling bench experience, and industry thought leaders that are considered subject matter experts in biomarkers, biosimilars, immunoassays, and other innovative bioanalytical methods. This team also includes a Quality Assurance team that averages 20 years of experience establishing processes and systems that comply with all applicable GxP regulatory requirements.

Proven experts at navigating the scientific and regulatory complexities of small and large molecule bioanalysis, our team combines highly specialized expertise, veteran insights, and innovative technology to accelerate success through every phase of development – compressing your timeline from discovery to market, and exceeding your quality expectations all along the way.

Work with a Partner, Collaborate with a Problem Solver

Our team works every day to solve the most complex and demanding bioanalytical challenges our customers face. They are passionate about continually deepening their understanding of each study we support, so that we can anticipate and overcome problems before they arise. As a committed partner, we work collaboratively with our customers’ internal teams, scientist to scientist, to deliver the premier small and large molecule bioanalytical services needed to help pharmaceutical and biotechnology organizations more effectively bring life-changing biotherapeutic products to market.

To learn more about our global services, please contact:

BioAgilytix – US Headquarters
919-381-6097
[email protected]

2300 Englert Drive, Durham, NC, 27713

Our Laboratories

Durham Corporate HQ

This is BioAgilytix’s largest, most advanced laboratory, located in the Research Triangle Area of North Carolina. This location also serves as our Corporate Headquarters, where we combine specialized expertise, state-of-the-art technology, and deep regulatory knowledge to provide premier biologics services that accelerate global clinical studies through every stage of development.

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
  • ~ 470 employees
  • 89,109 total sq. ft.
  • Upcoming addition of second campus to bring total sq. ft. to ~265,0000

Boston Laboratory

BioAgilytix’s Boston laboratory 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 along with specialized diagnostic testing.

1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701

  • ~ 90 employees
  • 22,205 total sq. ft.

San Diego Laboratory

With advanced laboratories facilities in Durham, Boston, San Diego, Hamburg, Germany, and Brisbane and Melbourne, Australia we can support all global studies.

9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699

  • ~ 90 employees
  • 34,000 total sq. ft.

European HQ

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.

Lademannbogen 10
22339 Hamburg Germany
+49 40 526779 0
  • ~ 100 employees
  • 3,222 square meters

Brisbane Laboratory

BioAgilytix’s Brisbane laboratory is located in the Translational Research Institute (TRI) in Woolloongabba. TRI is focused ‘bench to bedside’ on the effective translation of research and innovation into improved healthcare, consistent with our mission of enabling future medicines.

37 Kent St,Woolloongabba
Queensland, 4102, Australia
  • ~ 90 employees
  • 25 square meters

Melbourne Laboratory

BioAgilytix’s Melbourne laboratory is located in Australia’s biomedical and clinical research hub and is co-located at the world-class Burnet Institute, the country’s largest Phase 1 unit to support all of your clinical needs. The Melbourne laboratory facilities are perfectly situated to benefit from the unique advantages of conducting studies in Australia.

85 Commercial Road, Melbourne
Victoria, 3004, Australia
  • ~ 90 employees
  • 1,566 square meters

Speak To A Scientist





    I consent to receive communications (which may include, phone, email, social, and re-targeting ads) from BioAgilytix. I understand I may proactively manage my preferences or opt-out of communications with BioAgilytix at any time using the unsubscribe link provided in all of BioAgilytix’s email communications and can learn more by reading the privacy policy.