We hope to see you at BEBPA held in Rotterdam, Netherlands from 24 – 26 September! Visit us to speak with our experts about our global, best-in-class, CMC biopharma analytical development and GMP testing services. Learn about our strategies for potency assurance and characterization approaches for your modality. Scientific Officer Jessica Bridges Weaver, Principal Investigator Julia Hecker, Director Business Development Ymke Van Der Geld, and Business Development Executive Konrad Jazgar will be onsite to answer your questions. Schedule a meeting with us in advance - https://bit.ly/3JqYDda #biopharmaceutical #CMC #bioassay #flowcytometry #science #InnovationInScience
BioAgilytix
Biotechnology Research
Durham, NC 42,149 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
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http://www.BioAgilytix.com
External link for BioAgilytix
- 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
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Are you interested in learning about the advancements in immunogenicity assessment for biotherapeutics? Sign up for our free seminar on 25 September at the BioM Biotech Cluster Development GmbH facility in Munich, Germany. Start with a Bavarian breakfast, followed by insights and networking with our scientists. BioAgilytix Scientific Officer Robert Nelson, PhD will share the current regulatory landscape for immunogenicity assessment and BioAgilytix Scientist Ellen Gattkowski will discuss the feasibility of singlicate analyses in regulated bioanalysis. Finally, our special guest Principal Scientist Gregor Jordan from Roche will discuss how we can harmonize immunogenicity assays. Stay up to date with the current immunogenicity trends and reserve your seat today: https://lnkd.in/eJsu_JtP #BioM #Munich #drugdevelopment #immunogenicity #biotherapeutics #biopharma #bioanalysis #InnovationInScience
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Join us for a free Xtalks webinar exploring how bioanalytical science is evolving to support multidomain biologics—including bispecifics, fusion proteins, and other complex modalities. Learn about emerging challenges and the strategies BioAgilytix scientists use to overcome them. Register: https://bit.ly/4myzzzK #AssayDevelopment #biologics #bioanalysis #multidomainbiologics #biotech #webinar #drugdevelopment
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Curious about the best approach for screening for pre-existing anti-AAV antibodies in gene therapy trials? Join Scientific Officer Robert Nelson, PhD and Business Development Director Valeria Ventura, PhD at the 26th International Reid Bioanalytical Forum (RBF) in Cambridge, UK from 8 – 11 September. We will discuss the differences between total antibody (TAb) and neutralizing antibody (NAb) screening assays for AAV-based therapeutics. This presentation will offer fresh insights into selecting the right tools to evaluate safety and efficacy in gene therapy development. You won’t want to miss this opportunity to gain practical insights for advancing gene therapy programs. Connect with our team at our booth and discuss how we can work together to support the success of your projects. Learn more about our Immunogenicity services here: https://bit.ly/4b6hbHY #Reid #BioAgilytix #GlobalReach #GeneTherapy #immunogenicity #DrugDevelopment #InnovationInScience
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How do you develop assays for multidomain biologics with unique structures and multiple mechanisms of action? In this upcoming webinar, BioAgilytix experts Lynn Kamen , Christopher Tiedje, Joshua Cubbison, and Lizabethann Nolff will share real-world strategies for supporting the bioanalysis of advanced biologic formats—from method development through validation and regulatory considerations. Register today: https://bit.ly/4myzzzK #AssayDevelopment #bioanalysis #biotherapeutics #multidomainbiologics #BioAgilytix
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We’re looking for a Scientist III (Principal Investigator) to join our Large Molecule (Biologics) LC/MS team at #BioAgilytix. In this role, you’ll apply your expertise in LC/MS method development, validation, and quantitative workflows to deliver high-quality, reliable data in a regulated environment. You’ll work closely with clients to understand project needs, present results, and provide scientific insight, bridging technical excellence with clear, confident communication. To Learn More>https://bit.ly/4mNEQD4 #Hiring #CareerOpportunites #LCMS
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Therapies are becoming increasingly complex, and your bioanalytical strategies must keep pace. Register for our upcoming webinar where BioAgilytix scientists will explore how to design robust, regulatory-ready bioanalytical methods for multidomain biologics. Learn best practices for pharmacokinetic and immunogenicity assay design considerations. Registration is free: https://lnkd.in/d5C9ne38 #AssayDevelopment #multidomainbiologics #pharmasolutions #bioanalytics #drugdevelopment
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We hope to see you at the Medicon Valley Alliance Good Morning Meeting on 9 September in Copenhagen, Denmark to meet with our experts and gain knowledge on recent advancements in PK and ADA bioanalysis. Sign up now for the event where we will share insights on the current regulatory landscape and case studies highlighting bioanalysis in drug development and alternative strategies towards an accelerated drug development pathway including fit-for-purpose immunogenicity assessment as part of preclinical studies, singlicate analysis and other hot topics in bioanalysis. Senior Director of Business Development Ymke Van Der Geld, Scientific Officer, Amanda Hays, PhD, Scientific Operations, Matthias Reichel, and Scientific Operations, Daniel Worms, PhD will be available to discuss your biotherapeutic needs. We look forward to seeing you there! Sign up today: https://bit.ly/4ehVOWY #drugdevelopment #biotherapeutics #biopharma #bioanalysis #InnovationInScience
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Thanks to everyone who stopped by Booth 9 at the AAPS Summer Scientific Forum! We enjoyed connecting and sharing how BioAgilytix supports drug development with GxP-compliant bioanalytical and CMC analytical solutions—spanning PK, immunogenicity, biomarkers, across complex modalities like siRNA therapeutics and ADCs. If we didn’t get the chance to dive into your specific challenges, our team is still here and ready to help. https://bit.ly/44luZLt
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The webinar “Navigating IDE and IVDR Requirements in Drug Development” is now available to watch on demand. Gain insights from our expert speakers and panelists on: -IDE requirements for assays used in clinical trial inclusion/exclusion -IVDR compliance pathways for clinical trials -Real-world experience to help meet regulatory expectations Watch Now: https://bit.ly/3ZIKoFW #AssayDevelopment #GeneTherapy
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