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Bioanalytical Laboratory Capabilities

Specialized Small and Large Molecule Contract Research Organization

BioAgilytix is a leading contract research organization that enables 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.

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BIOAGILYTIX: A global contract research Laboratory With Recognized bioanalysis Expertise

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 BPM team averages 10+ years of post-schooling bench experience, with more than 50% comprised of Ph.D. 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:

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Biomarkers

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Immunogenicity

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Cell-Based Assays

Pharmacokinetics
& Pharmacodynamics (PK/PD)

Diagnostic Testing

Through our CLIA-certified and CAP-accredited laboratory in Boston, we also provide services to develop, validate, and perform laboratory developed tests (LDTs) and FDA-cleared assays.

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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. With advanced laboratories facilities in Durham, Boston, San Diego, Hamburg, Germany, and Brisbane and Melbourne, Australia, we can support all global studies through every phase of development. We are committed to working scientist-to-scientist to deliver integrated bioanalytical solutions-helping your team navigate increasingly complex scientific and regulatory demands.

At all of our 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 upholds the same quality commitment to ensure the work is done efficiently, accurately, and to the highest performance standards.

Our lab services also go beyond our core competencies and technologies, as our staff is highly trained and exceedingly competent and we leverage every one of their skills to meet our client needs. This enables us to offer a wide range of supporting services, which are available to add-on to your existing projects or to utilize for a standalone assessment. Such services include spectroscopy, colorimetric analysis, HPLC, and more.

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Our Veteran Scientists Provide Leading-Edge Laboratory Services to Support Every Study Phase, Including:

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 de novo assay development services leverage the extensive and robust method development expertise of our scientists to design unique solutions optimized to your needs.

To confirm an assay’s precision, accuracy, and robustness under a range of conditions, BioAgilytix will evaluate and verify that its performance consistently meets quality and compliance standards. Assays validated within our lab include a validation report customized to your exact requirements, with parameters that include:

  • Accuracy
  • Intra- and inter-assay precision
  • Interference
  • Linearity and dilution
  • Long-term stability at -80°C
  • Reportable ranges and clinical reference ranges
  • Short-term stability at RT and 4°C
  • Specificity and sensitivity

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.

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.

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.

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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A PROVEN PARTNER TO INNOVATORS OF ALL SIZES ACROSS THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES

BioAgilytix is a CRO lab partner to many of the top global pharmaceutical and biotechnology companies. We also actively support innovators across other industries that are working to progress small and 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.

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Our Disease State Expertise Includes:
  • oncology
  • metabolic
  • Autoimmune
  • Neurology

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.

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    Immunogenicity

    Learn why BioAgilytix is a world-leading authority on immunogenicity studies related to ADA, NAb assay development and validation, isotyping, and more.
    See our Immunogenicity expertise