Our Capabilities

BioAgilytix is a leading contract research organization (CRO lab) specializing 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).

contract research organization (CRO Lab)At BioAgilytix, complexity is our specialty. We work scientist to scientist as a collaborative CRO lab partner to deliver integrated bioanalytical solutions for your toughest assay needs. In fact, we excel in some of the most demanding areas of bioanalysis today—biomarkers, biosimilars, ADCs, and more—where extensive, expert-level skill is required.

As a GLP / GMP-compliant CRO lab staffed by a team of veteran scientists, we provide the proven scientific and regulatory expertise needed to overcome bioanalytical complexities and avoid quality pitfalls in every phase. You won’t ever get our ‘B’ team, because we only have scientists with proven, highly specialized expertise – as reflected in their deep resumes, scientific accolades, and numerous publications in reputable journals.

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By extending your internal resources with our veteran staff, you’ll be able to take advantage of a unique depth and breadth of biologic expertise. Learn more about BioAgilytix’s unique bioanalytical capabilities below, and why you should consider making us your contract research organization of choice.

A CRO Lab with Specialized Large Molecule Focus.

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.

The BioAgilytix team averages 15+ years of bench experience, with more than half comprised of PhD and Masters-level scientists that have been working with leading pharmaceutical and contract research organizations for decades. They use their real-world, veteran insight to help our customers successfully navigate the inherent complexities of large molecule bioanalysis, for both scientific and regulatory demands.

A Team with Extensive Therapeutic Area Expertise.

Our scientific team’s collective experience supporting novel drug development for a range of disease areas has made BioAgilytix the go-to contract research organization for those looking to create more effective biologic therapeutics in these fields.

Our scientists have supported the development of several key drugs now on the market today, as well as an array of promising clinical candidates, and understand the nuances in scientific, regulatory, and data requirements across disease states – as well as the challenges to anticipate in each phase. We work proactively to mitigate your risk and solve problems quickly, so you can bring your life-saving innovations to fruition faster.

Disease States Include:

A Trusted Resource for End-to-End Bioanalytical Support.

Our CRO lab services support all bioanalytical needs from discovery to pre-clinical and clinical development, manufacturing, and post-marketing surveillance under non-GLP, spirit-of-GLP, GLP, GCP or GMP.

We excel in the scientifically demanding area of assay development, and can develop and pair customized assays with the optimal platform from our broad suite of technology options. Whether qualifying and validating assays, performing sample analysis, or supporting lot release testing for manufacturing, BioAgilytix uphold the same quality commitment to ensure the work is done efficiently, accurately, and to the highest performance standards.

Our Bioanalytical Laboratory Services Include:

A Proven Partner to Innovators of All Sizes.

BioAgilytix is a CRO lab partner to 21 of the top 25 pharmaceutical and biotechnology companies. We also actively support innovators across other industries that are working to progress large molecule breakthroughs, as well as smaller biotechs and emerging biopharmas.

Customers continue to choose us as their preferred bioanalytical contract research organization, not only because of our experience and track record, but for our uniquely collaborative approach. We believe in the power of partnership and strive to work as a seamless extension of your internal team, so that we can add the value of specialized insight wherever needed. You can view our case studies to learn more about how we work together to solve bioanalytical challenges, scientist to scientist.

Choose the bioanalytical CRO lab that can help you bring clarity to the complexities of biologics.

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