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BioAgilytix

BioAgilytix

Biotechnology Research

Durham, NC 38,243 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

    38,243 followers

    Scientific Officer Amanda Hays, PhD, will participate in several sessions at this year's American Association of Pharmaceutical Scientists (AAPS) | @aapscomms National Biotechnology Conference. Hot Topic Panel: Neutralizing Antibody Sample Testing and Report Harmonization - A timely discussion addressing variability, regulatory considerations, and the path toward greater standardization in NAb sample testing and reporting. Monday, May 5 | 3:00 PM Hot Topic Panel: Companion Diagnostics for AAV-Mediated Gene Therapy - A collaborative industry exchange on evolving expectations and strategies to support enrollment assays for AAV-based therapies. Tuesday, May 6 | 10:00 AM   Poster Session Host: A curated collection of posters highlighting innovation in bioanalytical and translational sciences. Tuesday, May 6 | 3:30 PM Stop by Booth 113 or schedule a meeting in advance to connect with Dr. Hays and our team of experts onsite to discuss your project needs.  #NBC2025 #GeneTherapy

  • View organization page for BioAgilytix

    38,243 followers

    Attending #ASGCT2025? Don’t miss our Wednesday lunch symposia “Overcoming Challenges for Advanced Therapeutics: Case Studies on Navigating the Unique Bioanalytical and CMC Characterization Landscape of Cell and Gene Therapies.” Scientific Officer Jessica Bridges Weaver will discuss critical considerations for designing and implementing potency assays as part of successful control strategies for ATMPs. She will highlight the variety of platforms and methodologies depending on the MOA of the therapeutic, phase of development, and availability of appropriate critical reagents. With over a decade of experience supporting the bioanalysis and CMC analytical testing of gene and cell therapies, our scientists have been at the forefront of the regulations around these emerging drug modalities. Stop by booth 1610, or visit our website to schedule a meeting to speak with an expert in New Orleans about your gene or cell therapy program: https://lnkd.in/eRtnwu4r #ASGCT2025 #CellandGeneTherapy #potencyassays

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  • View organization page for BioAgilytix

    38,243 followers

    Are you attending American Association of Pharmaceutical Scientists (AAPS) | @aapscomms National Biotechnology Conference?    Learn more about the BioAgilytix approach to biomarker assay development with our two posters:    - Qualification of the S-PLEX Neurology Panel 1 (GFAP, NfL & Tau) MSD assay presented by Sri Laxmanan - Qualification of a Novel Multiplex Assay for the Quantification of Chemokine Markers in Human Plasma and CSF Samples presented by Christian Braithwaite   Be sure to stop by booth 113 or schedule a meeting with our team today. We're looking forward to connecting with everyone! https://lnkd.in/gs2TY2P2   #NBC2025 #Biopharma #Biomarkers #InnovationinScience

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  • We are honored to have our poster, "𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝗦-𝗣𝗟𝗘𝗫 𝗡𝗲𝘂𝗿𝗼𝗹𝗼𝗴𝘆 𝗣𝗮𝗻𝗲𝗹 𝟭 (𝗚𝗙𝗔𝗣, 𝗡𝗳𝗟 & 𝗧𝗮𝘂) 𝗠𝗦𝗗 𝗔𝘀𝘀𝗮𝘆", selected by FAAPS President, Russell Weiner, PhD, for his special poster collection at the American Association of Pharmaceutical Scientists (AAPS) | aapscomms National Biotechnology Conference! Thank you to Sri Laxmanan for your hard work on this poster presentation. Your expertise is valued and recognized by AAPS and all of us at BioAgilytix. If you’re attending #NBC2025, be sure to stop by Sri’s poster presentation to learn about the qualification of an S-PLEX Neurology Panel 1 (NfL, Tau and GFAP) in plasma and CSF that resulted in an assay with precision and accuracy at low fg/mL concentrations. You won’t want to miss it! 𝗪𝗮𝗻𝘁 𝘁𝗼 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝘄𝗶𝘁𝗵 𝗼𝘂𝗿 𝘁𝗲𝗮𝗺? 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 𝘁𝗼𝗱𝗮𝘆: https://lnkd.in/gs2TY2P2 #Biopharma #Biomarkers #InnovationinScience

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  • View organization page for BioAgilytix

    38,243 followers

    Did you know that 11,215 lbs of CO₂ is equivalent to driving from New York to Los Angeles and back—twice? In 2024, our employee resource group, Earth to BAL, reported that #BioAgilytix diverted over 4,300 lbs of waste through composting, avoiding more than 11,200 lbs of CO₂ and 448 lbs of methane emissions from our Durham labs. Sustainability is at the core of how we operate. From reducing consumption and waste to improving energy efficiency and supporting green transportation, we’re committed to implementing processes that minimize our environmental impact. Learn more about the steps we’re taking towards a more equitable and environmentally conscious future. Download our Sustainability Report here: https://lnkd.in/e_UT7Qgp #EarthDay2025 #Sustainability #OurPowerOurPlanet #EarthActionDay

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  • Multiplex assays are a powerful tool in biomarker analysis, allowing for the simultaneous measurement of multiple analytes while reducing sample volume, time, and labor. Learn how our team developed a custom method to measure seven chemokines of interest in various autoimmune, oncological, and neurodegenerative diseases in both plasma and CSF during Christian Braithwaite's poster session at American Association of Pharmaceutical Scientists (AAPS) | aapscomms #NBC2025: 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗮 𝗡𝗼𝘃𝗲𝗹 𝗠𝘂𝗹𝘁𝗶𝗽𝗹𝗲𝘅 𝗔𝘀𝘀𝗮𝘆 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗤𝘂𝗮𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗖𝗵𝗲𝗺𝗼𝗸𝗶𝗻𝗲 𝗠𝗮𝗿𝗸𝗲𝗿𝘀 𝗶𝗻 𝗛𝘂𝗺𝗮𝗻 𝗣𝗹𝗮𝘀𝗺𝗮 𝗮𝗻𝗱 𝗖𝗦𝗙 𝗦𝗮𝗺𝗽𝗹𝗲𝘀. Want to learn more? 𝗦𝘁𝗼𝗽 𝗯𝘆 𝗯𝗼𝗼𝘁𝗵 𝟭𝟭𝟯 𝗼𝗿 𝘀𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 with our experts today: https://bit.ly/4jsVIxj #Biopharma #Biomarkers #InnovationinScience

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  • View organization page for BioAgilytix

    38,243 followers

    Leveraging ultrasensitive platforms like 𝗠𝗦𝗗 𝗦-𝗣𝗟𝗘𝗫 for measuring low abundance biomarkers such as NfL, GFAP, and Tau can enhance data quality and the integrity of results. Learn about the qualification of an S-PLEX Neurology Panel 1 (NfL, Tau and GFAP) in plasma and CSF that resulted in an assay with precision and accuracy at low fg/mL concentrations during Sri Laxmanan’s poster session at the American Association of Pharmaceutical Scientists (AAPS) | @aapscomms National Biotechnology Conference (NBC): 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝗦-𝗣𝗟𝗘𝗫 𝗡𝗲𝘂𝗿𝗼𝗹𝗼𝗴𝘆 𝗣𝗮𝗻𝗲𝗹 𝟭 (𝗚𝗙𝗔𝗣, 𝗡𝗳𝗟 & 𝗧𝗮𝘂) 𝗠𝗦𝗗 𝗮𝘀𝘀𝗮𝘆. Will you be attending? Schedule a meeting with our team: https://bit.ly/4jsVIxj #NBC2025 #Biopharma #Biomarkers #InnovationinScience

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  • Accurately measuring free drug, total antibody, and conjugated drug is critical for understanding 𝗔𝗗𝗖 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗸𝗶𝗻𝗲𝘁𝗶𝗰𝘀, but it presents a significant challenge in 𝗔𝗗𝗖 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗿𝗼𝗴𝗿𝗮𝗺𝘀. BioAgilytix eliminates the challenge of finding a single vendor with all the necessary experience and expertise. Our team of experts ensure accurate, reliable measurements while meeting regulatory expectations and supporting the overall success of your program. 𝗕𝗲𝗹𝗼𝘄 𝗮𝗿𝗲 𝘁𝗵𝗿𝗲𝗲 𝘁𝗶𝗽𝘀 𝘁𝗼 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝗳𝗼𝗿 𝗲𝗻𝗵𝗮𝗻𝗰𝗶𝗻𝗴 𝗮𝗰𝗰𝘂𝗿𝗮𝗰𝘆 𝗶𝗻 𝗔𝗗𝗖 𝗣𝗞 𝗺𝗲𝗮𝘀𝘂𝗿𝗲𝗺𝗲𝗻𝘁𝘀. ⬇️    Speak to our experts to learn how BioAgilytix provides both the assay platforms and technical experience to support pharmacokinetics for your program:  https://lnkd.in/e7_WbES   #BioAgilytix #AntibodyDrugConjugate #Immunoassays #LCMS #Bioanalysis 

  • View organization page for BioAgilytix

    38,243 followers

    We are back from CASSS – Sharing Science Solutions Bioassay! Our team came away with new perspectives and practical takeaways from a rich scientific agenda at CASSS Bioassay 2025—covering everything from assay strategies for multi-specific antibodies to key considerations in the evolving field of cell and gene therapies. Two sessions that stood out focused on bioassays and ADCs—highlighting both technical innovations and strategic approaches to assay design, validation, and the shifting regulatory landscape. It was great to see our featured poster, presented by Gopit Shah, PhD, lead to in-depth discussions about risk mitigation strategies, especially in scenarios where key reagents may become unavailable. A special thank you to Jessica Bridges Weaver, Cameron Bullard, and Justin Pittman (he/him) for being a part of this great event. We can’t wait to participate again next year! Whether you attended CASSS Bioassay or are simply interested in these topics, we’d love to connect and keep the conversation going! Speak to a scientist today: https://lnkd.in/e7_WbES#CASSS #Bioassays #ADCs #CellAndGeneTherapy #AssayDevelopment

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  • We’re looking forward to attending the Festival of Biologics next week, April 23–24, in San Diego, CA! Gopit Shah, PhD will be presenting a poster titled: 𝗔𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗕𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿 𝗜𝗻𝘀𝘂𝗹𝗶𝗻 𝗧𝗲𝘀𝘁𝗶𝗻𝗴: 𝗔𝗻 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗲𝗱 𝗜𝗻 𝗩𝗶𝘁𝗿𝗼 𝗣𝗼𝘁𝗲𝗻𝗰𝘆 𝗔𝘀𝘀𝗮𝘆 𝗮𝘀 𝗮 𝗥𝗲𝗽𝗹𝗮𝗰𝗲𝗺𝗲𝗻𝘁 𝗳𝗼𝗿 𝗔𝗻𝗶𝗺𝗮𝗹-𝗕𝗮𝘀𝗲𝗱 𝗠𝗲𝘁𝗵𝗼𝗱𝘀. This work highlights the development of a robust, cell-based assay for insulin glargine that offers improved precision, range, and reproducibility over traditional in vivo methods. By optimizing the in vitro potency assessment approach, this assay supports global regulatory goals to reduce animal testing while enhancing scientific rigor in insulin potency testing. Interested in learning how BioAgilytix can provide CMC and Bioanalytical solutions to support your next biologics and biosimilars project? 𝗦𝗽𝗲𝗮𝗸 𝘁𝗼 𝗮 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝘀𝘁 𝘁𝗼𝗱𝗮𝘆: https://bit.ly/44luZLt #FestivalOfBiologics #Biosimilars #InVitroTesting #RegulatoryScience

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