Our Capabilities
Our Capabilities

Bioanalytical Laboratory Capabilities

Specialized Large Molecule Contract Research Organization

BioAgilytix is a leading contract research organization 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). We work scientist to scientist as a collaborative CRO 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, where extensive, expert-level skill is required.

Find Out More About Our Expert Large Molecule Capabilities:

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What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.

BioAgilytix: A Contract Research Laboratory With Recognized 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 post-schooling bench experience, with more than 35% 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. Our assay focus includes:

biomarkers

Biomarkers

immunogenicity

Immunogenicity

pharmacokinetics

Pharmacokinetics

cell-based assays

Cell-Based Assays

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 have the capabilities to work with sponsors in both our USA Headquarters in North Carolina and in our European Headquarters in Hamburg, Germany.

At both locations our scientists 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.

imunnogenicity stages

Our veteran scientists provide innovative laboratory services to support every phase of large molecule studies, including:

Assay Development

This scientifically demanding area is where BioAgilytix excels, collaborating alongside your internal team to characterize your novel compounds to support rapid decision making on next steps. Our custom assay development services leverage the extensive and robust method development expertise of our scientists to design unique solutions optimized to your needs.

Assay Validation

To confirm an assay’s precision, accuracy, and ruggedness under a range of conditions, BioAgilytix will evaluate and verify that its performance consistently meets quality and compliance standards.

Sample Analysis

Leveraging the comprehensive platform suite within our bioanalytical lab, we help customers realize the benefits of greater throughput, better reproducibility, and high analysis accuracy. We are capable of rapidly delivering high-quality, reliable results for studies at every preclinical and clinical phase.

Lot Release Testing

As a GLP and GMP bioanalytical lab facility, BioAgilytix supports product releases of biologics, biosimilars, and biobetters including optimization of assays in support of process improvement and measurement of peptides, proteins, and monoclonal antibodies in the presence of various formulations and excipients.

Post-Marketing Surveillance

Your work doesn’t end at product launch and neither do our bioanalytical laboratory services. We provide post-market surveillance with ongoing data gathering and sample analysis from broader market populations to ensure continued quality and compliance.

immunogenicity offer

bioanalytical buyers guide cell based assay services

The Bioanalytical Buyer's Guide: Choosing the Right CRO Partner

Download this helpful resource to discover the 8 key selection criteria you should consider when evaluating a bioanalytical CRO to ensure a successful partnership.

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biosimilars development

A Proven Partner to Innovators of All Sizes Across the Pharmaceutical and Biotechnology Industries

BioAgilytix is a CRO lab partner to 23 of the top 25 global 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. Learn more about how we work together to solve bioanalytical challenges, scientist to scientist.

 

Rely on a World Class Team of Scientists 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 organizations 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.

cell-based assay expertise

Our Disease State Expertise Includes:

  • Oncology
  • Metabolic
  • Automimmune
  • Neurology

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immunogenicity icon

Immunogenicity

See how we employ world-leading immunogenicity expertise to measure adverse immune reactions for many drug- and disease-specific aspects.

Explore our immunogenicity services

biomarkers icon

Biomarkers

Learn how we will translate our experience working with over 500 biomarkers in singleplex and multiplex formats to your project’s success.

See our biomarker expertise