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BioAgilytix

BioAgilytix

Biotechnology Research

Durham, NC 49,674 followers

Enabling the breakthroughs of tomorrow, today.

About us

BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.

Website
http://www.BioAgilytix.com
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Headquarters
Durham, NC
Type
Privately Held
Founded
2008
Specialties
Immunoassays, Cell-Based Assays, Immunogenicity, Pharmacokinetics, Biomarkers, Large molecule bioanalysis, Bioanalytical testing, Assay Development & Validation, Bioassays, Biosimilars, Gene Therapy, and Immuno-oncology

Locations

Employees at BioAgilytix

Updates

  • View organization page for BioAgilytix

    49,674 followers

    Last chance to register! Join us on Tuesday 2 June for our morning seminar hosted by Medicon Valley Alliance in Copenhagen, Denmark. Registration is closing soon, so reserve your seat today! As drug modalities become more complex and timelines tighten, the need for fit-for-purpose, risk-based bioanalytical strategies continues to grow. Scientific Officer Robert Nelson, PhD will discuss recent advancements and key topics in PK, immunogenicity (ADA/NAb), and biomarker bioanalysis. Our subject matter experts Tim Schauer and Laura von Berg will share insights from case studies, including a re-evaluation of the traditional 3-tier immunogenicity testing paradigm through a 1-tier signal-to-noise (SNR)-based approach, and the transition from duplicate to singlicate analysis. If you’re involved in bioanalysis, clinical development, or regulatory science, this session offers relevant scientific perspectives you can apply in your programs, and an opportunity to connect with peers. Business Development Manager Konrad Jazgar will also be onsite to discuss your upcoming projects. Seats are limited — don’t miss out. Register now: https://lnkd.in/e69MzYR3 #Bioanalysis #DrugDevelopment #Immunogenicity #Biomarkers #LifeSciences #InnovationInScience

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  • View organization page for BioAgilytix

    49,674 followers

    Join us in Geneva, Switzerland for an engaging morning seminar and networking breakfast hosted by Campus Biotech on 10 June. This session will explore how regulated bioanalysis is evolving in response to increasingly complex therapeutic modalities and the growing need to accelerate drug development without compromising data quality. Robert Nelson, PhD, Scientific Officer, and Laura von Berg, PhD, Scientific Operations will share insights into current challenges and emerging thinking across pharmacokinetics (PK), immunogenicity (ADA/NAb), and biomarker bioanalysis—focusing on how scientific and regulatory principles are applied in practice. The discussion will also address some of today’s most relevant industry questions highlighting key hot topics shaping regulated bioanalysis. In addition, Dany Spaggiari, PhD, Senior Scientist Bioanalysis of Debiopharm, will present a case study exploring the analytical challenges associated with quantifying free payloads in antibody-drug conjugates (ADCs), highlighting why tailored assay strategies are critical for these increasingly complex modalities. We will also share practical perspectives on evolving approaches such as the transition toward singlicate ADA analysis and what it means for long-standing practices like duplicate testing. You’ll have the opportunity to connect with Nadia Drider, PhD, Senior Director Business Development, to discuss the needs of your upcoming projects. Start your day with fresh perspectives and valuable networking over breakfast with peers in the field. Register now to secure your place: https://lnkd.in/egQ7jKVN #Bioanalysis #DrugDevelopment #Pharma #Biotech #RegulatorySciences #LifeSciences #Networking #GenevaEvents

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  • Over the past year, the demand for GMP ready analytical support has continued to accelerate, especially as more complex modalities move toward the clinic. One year after expanding our GMP testing capabilities in Morrisville, North Carolina and Hamburg, Germany, we are seeing firsthand how critical that investment has become. By aligning our GMP capabilities across the U.S. and Europe, we are helping sponsors move more seamlessly from development into regulated testing. From method qualification and validation to lot release and stability programs, the goal is simple. Reduce variability, strengthen tech transfer, and support regulatory readiness from the start. As pipelines continue to evolve across cell and gene therapies, oligonucleotides, and ADCs, analytical readiness is no longer a downstream step. It is a critical part of getting to the clinic. If this is a focus for your team, we would be glad to connect Read More: https://bit.ly/4frE1PI

  • TIDES USA 2026 is right around the corner. If you’re working on oligonucleotide, peptide, or mRNA programs, and thinking through analytical strategy, CMC planning, or assay alignment this is a great time to connect. We’ll be onsite at Booth #130. If you’d like to talk through your program before or during the conference, you can schedule time here:https://bit.ly/4t5yiCv.

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  • TIDES USA 2026 is right around the corner. If you’re working on oligonucleotide, peptide, or mRNA programs, and thinking through analytical strategy, CMC planning, or assay alignment this is a great time to connect. We’ll be onsite at Booth #130. If you’d like to talk through your program before or during the conference, you can schedule time here:https://lnkd.in/eVE9G_9r

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  • View organization page for BioAgilytix

    49,674 followers

    Join us in Copenhagen, Denmark on Tuesday 2 June for a morning seminar hosted by Medicon Valley Alliance. Scientific Officer Robert Nelson, PhD will share recent advancements and key topics in regulated bioanalysis. As therapeutic modalities become increasingly complex and timelines accelerate, bioanalytical strategies continue to evolve. This session will explore current perspectives in PK, immunogenicity (ADA/NAb), and biomarker bioanalysis. Tim Schauer and Laura von Berg from our Hamburg scientific team will share how fit-for-purpose strategies, risk-based decision-making, and thoughtful assay design are applied in drug development programs, supported by practical case studies and regulatory insight. You’ll also have the opportunity to connect with Business Development Manager Konrad Jazgar to discuss your upcoming projects. If you're involved in bioanalysis, clinical development, or regulatory strategy, this session offers both scientific insight and valuable networking. Sign up for the free seminar here: https://lnkd.in/e69MzYR3 #Bioanalysis #DrugDevelopment #Immunogenicity #Biomarkers #LifeSciences #InnovationInScience

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  • Developing gene and cell therapies requires more than great science—it requires data you can trust. At ASGCT 2026, our team will be sharing how BioAgilytix supports: ✔ PK & Biomarkers ✔ Immunogenicity ✔ CMC Analytical Development ✔ GMP QC Testing Services ✔ Complex modality programs Visit us at Booth 1301 to discuss your program and timelines. May 12–14 | Boston #ASGCT2026 #GeneTherapyDevelopment #BioAgilytix #Biopharma

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