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Bioanalytical and Biomarker Sciences | ImmunologixLaboratory Services and Scientific Strategies that advance Drug Development Committed to customized scientific partnerships to deliver life changing th ...Bioanalytical and Biomarker Sciences | Immunologix Skip to content Laboratory Services Bioanalytical Services Immunogenicity Cell Based Assays Biomarker Services Critical Reagents Gene & Cell Therapy Flow CytometryTranslational SciencesTechnologies Process & Strategy Laboratory Equipment IndustriesResources Scientific Content Library Rethinking Bioanalysis Discussion Forum News Events & WebinarsAbout Our Team Our Facility Careers Contact Us Row edge-slant Shape Decorative svg added to bottom Laboratory Services and Scientific Strategies that advance Drug Development Committed to customized scientific partnerships to deliver life changing therapies Meet With our Team Events and Webinars Designed by Scientists, Run by Scientists Science-First Partnership Leveraging our team of global experts to partner with clients, providing proven scientific strategies and technical solutions Download Our Capabilities Flyer Scientific Experts Laboratory & Translational Sciences Offering GLP and GCP compliant laboratory capabilities focused on biomarkers and bioanalysis of biologics, cell & gene therapy and nucleic acid based therapeutics. Our deep technical skills in ligand binding, cell-based and qPCR assays coupled with scientific consultation from our Translational Sciences team offers an integration of strategic, scientific and technical expertise that is unparalleled within our industry. This enables our team to deliver valuable scientific insights that accelerate decision-making and the overall course of drug development programs for our clients. See our Translational Sciences Bioanalytical Sciences PK assays in support of large molecule, cell and gene therapy, and nucleic acid-based biotherapeutics Learn about the Science Immunogenicity ADA and NAb assays to support all biologic modalities, including C> and nucleic acid-based therapeutics Learn about the Science Cell based assays Supporting neutralizing antibody, cell proliferation, potency and cell-based PK assays Learn about the Science Biomarker Sciences Context of use driven de novo, multiplex, and commercial kit assays Learn about the Science Critical Reagents Critical reagent labeling and analytical characterization services Learn about the Science Gene & Cell TherapyPharmaco/cellular kinetics, PD, safety, immunogenicity, biodistribution, expansion, persistence, cytokine analysis (CRS monitoring) and phenotypic analysesLearn about the Science The Immunologix Difference Strategic and Scientific Partnership for large molecule bioanalytical and biomarker sciences. Leadership Unparalleled Scientific Leadership Composed of globally recognized thought leaders in bioanalysis, immunogenicity and biomarkers, our team brings a proven track record of influencing industry best practices and regulatory guidance while engaging and growing the next generation of scientists. In addition to setting scientific strategy for our organization, our leaders provide direct mentorship to our internal scientific team and hold multiple open office hours each week to ensure that our scientists, and thereby our clients’ projects, benefit from the collective experience of the senior team. At Immunologix, we believe that great science is achieved by developing great scientists. Read More >> Discover our technologies Integrated Team Translational Sciences - Integrated drug development and laboratory sciences expertise Bringing decades of drug development industry experience to bear to truly understand our client’s challenges and perspectives, we ensure all our assays are grounded in deep understanding of the drug program and clinical questions being addressed and meet the expectations of regulators. The remit of all of our Translational Scientists covers everything from scientific advising to developing therapeutic molecule specific biomarker and bioanalytical strategies, to fully integrated FTE models, sitting directly on client project teams. Internally, they serve as scientific advisors and mentors and are integral members of our assay development project teams, where they work closely with our principal investigators and laboratory scientists to ensure the methods we develop are designed to support our client’s assets through all phases of drug development. Read More >> Meet Our Team Integrated Team Translational Sciences - Integrated drug development and laboratory sciences expertise Bringing decades of drug development industry experience to bear to truly understand our client’s challenges and perspectives, we ensure all our assays are grounded in deep understanding of the drug program and clinical questions being addressed and meet the expectations of regulators. The remit of all of our Translational Scientists covers everything from scientific advising to developing therapeutic molecule specific biomarker and bioanalytical strategies, to fully integrated FTE models, sitting directly on client project teams. Internally, they serve as scientific advisors and mentors and are integral members of our assay development project teams, where they work closely with our principal investigators and laboratory scientists to ensure the methods we develop are designed to support our client’s assets through all phases of drug development. Read More >> Meet Our Team High Science and Quality Science-first strategies that deliver quality data A dedicated scientific team is formed to ensure your assay development project benefits from our triad of scientists with different, critical perspectives: (1) Your Principal Investigator organizes, drives and communicates; (2) Your development scientist leads technical aspects and benchwork; and (3) Your Translational Scientist guides assay development strategy to ensure your assay meets necessary performance criteria and regulatory expectations. Our commitment to high science is also reflected in our measured strengths-focused growth of our scientific team that provides 3 months of training prior to integration into project teams. This fosters our culture of learning and mastery and ensures quality results. Read More >> Discover our resources A Customized Approach Science-first strategies to meet your specific program needs Your Science and Challenges Project Alignment Initiating Our Collaborations Execution and Delivery Your Science and Challenges Our rigorous project intake process ensures that we truly customize our approach to deliver top quality science.  We dive deeply into the details of the therapeutic molecule, its mechanism of action and therapeutic hypothesis to build a strong biological understanding of the project and then delve into specifics of study design, available reagents, appropriate technology platforms and assay formats to ensure that the assays we deliver are best suited to meet the needs of the program.  From a business practice perspective, we are dedicated to flexing to our clients’ preferred working styles and scientific engagement needs to ensure that information flow is clear, comprehensive and timely.   Project Alignment Following our client intake meeting, the scientific, technical and logistical aspects of your project are reviewed by our senior Translational Sciences team, bringing together all relevant project-specific expertise to provide strategic and operational insight and highlight any potential challenges. You will receive our detailed proposal as a report-out from those discussions. Initiating Our Collaborations Promptly after agreement, you will be connected with your dedicated Principal Investigator to initiate communications and project start-up. Thereafter, the project team will assign a lead developer, align on the appropriate level of Translational Sciences support for the specific project and hold an internal kickoff meeting where experimental strategy is set prior to initiation of experiments. Execution and Delivery Your Principal Investigator will provide timely project updates and any additional communications critical to project success. Our proven quality management system and current compliance processes, coupled with a fully implemented project informatics system ensure all aspects of your project meet or exceed requirements. All key milestones, labwork, documentation, materials and sample management, as well as data delivery and reports will be planned, executed, and delivered. Meet With our Team Row edge-slant Shape Decorative svg added to bottom Voice Of Our Clients Chief Development Officer Boston Biotech “We greatly appreciate the effort you and the Immunologix team have provided on this over the last few weeks to enable the data generation in a timely manner.” Executive Director, R&D Large Boston BioPharma "We greatly appreciate your team’s focus in accommodating our challenging Phase 3 timelines." Associate Director Mid-size US Biotech “We want to thank you for all your dedication and hard work in helping us reach this milestone.” Sr. Outsourcing Manager Large US Pharma "Our auditors did note that the processes and systems she reviewed seem very robust and that it is clear that the organization is well-suited to conduct work for GLP and GCP studies.“ Clinical Operations Manager Korean Biopharm “One of your other clients has introduced [us] to your company and recommended Immunologix to support our clinical assays.” Our Recent Scientific Articles Bioanalysis Kayla J. Spivey February 23, 2026 — Strategic Bioanalytical Intake: Five Questions That Define Large Molecule Program Success Immunogenicity Kayla J. Spivey April 3, 2025 — Rational Is Not Radical: A Scientific Perspective on Immunogenicity Risk Assessment Uncategorized Kayla J. Spivey January 30, 2025 — The Immunologix Difference: A Capabilities Summary At Immunologix Laboratories, we provide integrated laboratory and scientific services for drug… Row edge-slant Shape Decorative svg added to top Talk To A Scientist Get started on your project today. Meet with our Team We use cookies to ensure that we give you the best experience on our website. Continued use of our site constitutes acceptance of our Privacy Policy and GDPR Policy. Contact 855-523-72764919 Memorial Hwy, Suite 103, Tampa, FL 33634info@immunologixlabs.com Connect Laboratory Services Bioanalytical Services Immunogenicity Cell Based Assays Biomarker Services Critical Reagents Gene & Cell Therapy Flow CytometryTranslational SciencesTechnologies Process & Strategy Laboratory Equipment IndustriesResources Scientific Content Library Rethinking Bioanalysis Discussion Forum News Events & WebinarsAbout Our Team Our Facility Careers Contact Us About Immunologix Your dedicated strategic and scientific drug development partner from bench to bedside since 2012. © 2026 All Rights Reserved. Powered by GDPR Policy Privacy Policyenusen-US1772679121https://immunologixlabs.com

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