BioAgilytix’s advanced laboratory in the Research Triangle area of North Carolina serves as our USA headquarters, where we combine specialized expertise, state-of-the-art technology, and deep regulatory knowledge to accelerate large molecule global studies through every stage of development.
The services we offer through our USA lab include development and validation of biomarker, immunogenicity, pharmacokinetics (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 large molecule bioanalytical testing.
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While BioAgilytix is specialized in large molecule bioanalysis, we are broad in our capabilities to support the end-to-end needs of global studies for biotherapeutics development. Our USA 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 a seamless solution for their range of biologic drug development requirements, and a single partner to streamline and accelerate projects that have the potential to save patient lives.
Our USA scientists possess leading expertise to support new advancements in gene therapy, immuno-oncology, biosimilars, and other innovative biotherapeutic solutions. We work collaboratively with internal teams to deliver science-driven bioanalytical services related to:
Our USA team has particular strength in biomarker development and validation, having worked with over 500 analytes in singleplex and multiplex formats targeting a wide range of disease states. In fact, our leadership team is helping to set the industry best practices for bioanalytical biomarkers by contributing to the evolving narrative around standardization and regulation in this rapidly expanding field of study. Part of our biomarker offering includes access to our menu of over 400 biomarkers, featuring over 120 validated biomarkers, which we can leverage to help streamline the time and cost needed for biotherapeutics development.
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.
Our USA lab offers high-quality PK assay procedures and results strictly in compliance with GLP / GMP regulations and in accordance with international regulatory standards (FDA, EMEA, and ICH). Our scientists are experienced in supporting PK assessments in a variety of species including rodents, humans, and non-human primates, and in multiple matrices such as serum, plasma, urine, and saliva.
BioAgilytix’s USA lab is able to develop and validate custom cell-based assays in line with all relevant GLP and GMP regulatory guidelines and recommendations. Our veteran team possesses expertise with primary cells and transformed cell lines, and are expert in performing cell-based assays to evaluate a variety of functional and biochemical effects, including techniques to support neutralizing antibody (NAb) assays, relative potency assays, mechanism of action studies, drug combination analysis, and more.
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 USA 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.
Our recently expanded 54,000+ square foot USA 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 USA lab gives customers a high-capacity facility that can support an array of 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:
The best science demands the best people, and our USA lab is headed by an unparalleled team of veteran scientists, 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 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.
Our USA 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 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 USA lab and the global services we provide, please contact these members of our leadership team:
Afshin Safavi, Ph.D.
Global Chief Scientific Officer
USA Chief Scientific Officer
2300 Englert Drive, Durham, NC, 27713