BioAgilytix

BioAgilytix

Biotechnology Research

Durham, NC 30,283 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.

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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    30,283 followers

    Don’t miss it! Visit Scientific Officer @RobertNelson, PhD during Poster Session II to learn about assays to detect Anti-AAV antibodies in support of gene therapies. In the poster, we highlight the validation of a total antibody assay (TAb) and a neutralizing antibody (NAb) assay for detection of anti-AAV antibodies for enrollment of patients into a gene therapy clinical study and how the two strategies compare. Poster Session II will take place on Wednesday, 23 October from 13:30 – 15:00 during the @european-society-for-gene-and-cell-therapy event in Rome, Italy. Be sure to schedule a meeting with our experts onsite or stop by our booth E14 to learn about our complete package of pharmacokinetic (PK), immunogenicity, biomarker, and CMC bioanalytical testing services. https://bit.ly/3zIgOXn #ESGCT2024 #LaNuvola #genetherapy #celltherapy #cellandgenetherapy #CMC #potencyassays #immunogenicity #PCR #flowcytometry

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    30,283 followers

    Visit us at booth E14 during @european-society-for-gene-and-cell-therapy held in Rome, Italy from 22 – 25 October to discuss your cell or gene therapy project with our experts onsite. With over a decade of experience supporting the bioanalysis of gene and cell therapies, our scientists have been at the forefront of the evolving regulations around these novel drug modalities. Be sure to attend two poster presentations by Scientific Officer Robert Nelson, PhD. Learn more about the presentations and schedule a meeting with us in advance. https://lnkd.in/ehziJGag #ESGCT2024 #LaNuvola #genetherapy #celltherapy #cellandgenetherapy #CMC #potencyassays #immunogenicity #PCR #flowcytometry

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  • View organization page for BioAgilytix, graphic

    30,283 followers

    We're just one week away from the upcoming @CHI Immunogenicity and Bioassay Summit in Washington, DC. Schedule a meeting with Chief Scientific Officer @Jim McNally Ph.D., Scientific Officer @Lynn Kamen Ph.D., and Business Development Director @Reed Lyon at booth 5 to discuss your bioanalytical project needs. As a leading global bioanalytical laboratory, we provide pharmacokinetic (PK), immunogenicity, biomarker, and CMC bioanalytical testing services in a GxP environment. Our scientific expertise and state-of-the-art instrumentation ensure high-quality, tailored services to meet all your bioanalytical needs. Schedule a meeting. https://bit.ly/3zC6Tm4 #CHIImmunoBio #bioassay #immunogenicity #immunoassay #cellandgenetherapy #biologics #NAbAssays #ADAAssays

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  • View organization page for BioAgilytix, graphic

    30,283 followers

    BioAgilytix is excited to share that we will be attending @AAPS PharmSci360 in Salt Lake City, Utah. As a trusted partner of top biopharma organizations, we take pride in our exceptional track record, regulatory knowledge, and industry leadership throughout all phases of drug development. Join us at Booth 1818 to meet our team and explore how we can partner to support your drug development project. #aaps2024 #ParmSci360 #drugdevelopment #biologics #Biopharma

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    30,283 followers

    BioAgilytix Scientific Officer @Lynn Kamen and Merck Director @Weifeng Xu will present “Overcoming Drug and Target Interference in ADA and NAb Assays." at the @CHI Immunogenicity & Bioassay Summit short course on October 15th from 2:00-5:00 PM. In this course, you'll discover how soluble drugs, drug targets, and matrices can often complicate the detection of anti-drug antibodies. While navigating these challenges may not always be simple, they can be effectively managed through a well-structured assay. This session will provide an overview of different types of interferences, along with the current methodologies and strategies being utilized to resolve or minimize them. It's an excellent chance to explore innovative approaches aimed at improving assay accuracy. Whether you're a seasoned expert or new to the field, this course offers invaluable insights that you won't want to miss! Schedule a meeting with Dr. Kamen and our team of experts in Washington to discuss your next immunogenicity project. https://bit.ly/3zC6Tm4 #CHIImmunoBio #bioassay #immunogenicity #immunoassay #cellandgenetherapy #biologics #NAbAssays #ADAAssays

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    30,283 followers

    Have you signed up for this year’s @CHI Immunogenicity and Bioassay Summit? You won’t want to miss Chief Scientific Officer Jim McNally's short course on “Recent Advances in Cell and Gene Therapy.” Dr. McNally will delve into a range of cutting-edge topics, including the immunogenicity assessment of cell therapies, recent developments in CAR T cells and edited stem cells, and the immunogenicity evaluation of gene therapies. Additionally, he will share new data on pre-existing reactivity for adeno-associated virus (AAV), advances in redosing strategies, and the application of current guidelines to novel modalities. Make sure to visit our thought leaders at Booth 5 to discuss how we can leverage our extensive experience to support your next project. Schedule a meeting today.https://bit.ly/3zC6Tm4 #CHIImmunoBio #bioassay #immunogenicity #immunoassay #cellandgenetherapy #biologics #NAbAssays #ADAAssays

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  • View organization page for BioAgilytix, graphic

    30,283 followers

    Register for the @CHI Immunogenicity & Bioassay Summit short course on neutralizing antibody assay development led by Chief Scientific Officer Jim McNally and Scientific Officer Lynn Kamen on October 15th from 9 -12 PM. This course will explore essential technical elements involved in NAb assay design, including how to choose the right assay format, optimization of critical parameters, and implementation during clinical studies. Additionally, they will share valuable case studies and examples that highlight challenges and solutions in NAb assay development. Don't miss this opportunity to enhance your understanding and skills in NAb assay development. Schedule a meeting with Dr. McNally or Dr. Kamen onsite to discuss your next immunogenicity project. https://bit.ly/3zC6Tm4#CHIImmunoBio #bioassay #immunogenicity #immunoassay #cellandgenetherapy #biologics #NAbAssays #ADAAssays

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    30,283 followers

    Join us at the 16th Annual @CHI Immunogenicity & Bioassay Summit, where you can find us at Booth 5 from October 15-18, 2024, at the Watergate Hotel in Washington, D.C. We are the leading global bioanalytical service provider with extensive experience in immunogenicity and bioassay development, validation, and sample analysis. Schedule a meeting in advance to speak with our experts onsite about your project needs. https://bit.ly/3zC6Tm4 #CHIImmunoBio #bioassay #immunogenicity #immunoassay #cellandgenetherapy #biologics #NAbAssays #ADAAssays

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    30,283 followers

    Our team enjoyed being onsite at BEBPA in Prague, Czech Republic last week for the annual biopharmaceutical event in Europe. Our t-shirts were a hit! Even the BEBPA organizing team were awarded the latest design as a BioAgilytix prize. Our presentation from Principal Investigator Julia Hecker shared insights on developing and validating a Flow Cytometry potency assay. This led to an engaged discussion about the validation and assessment of instrumentation across sites. We were happy to meet face-to-face with so many attendees at our booth and discuss how our CMC biopharma analytical development and GMP testing services can support future potency assurance and characterization approaches. Overall, it was a great conference where learning and sharing with scientific leaders across the bioassay sector sparked inspiring conversations on how we can partner with clients for ADCs, mAb, LNP, mRNA for bioassays and complex platforms such as Flow Cytometry, SPR and LCMS for potency and characterization. Did you miss us at BEBPA? Be sure to reach out to our scientific team today: https://bit.ly/44luZLt

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