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
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.
Bioanalytical Sciences
PK assays in support of large molecule, cell and gene therapy, and nucleic acid-based biotherapeutics
Immunogenicity
ADA and NAb assays to support all biologic modalities, including C> and nucleic acid-based therapeutics
Cell based assays
Supporting neutralizing antibody, cell proliferation, potency and cell-based PK assays
Biomarker Sciences
Context of use driven de novo, multiplex, and commercial kit assays
Critical Reagents
Critical reagent labeling and analytical characterization services
Gene & Cell Therapy
Pharmaco/cellular kinetics, PD, safety, immunogenicity, biodistribution, expansion, persistence, cytokine analysis (CRS monitoring) and phenotypic analyses
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.
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.
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.
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.
A Customized Approach
Science-first strategies to meet your specific program needs
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.
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.
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.
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.
Voice Of Our Clients
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Read About Our Scientific Research
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Biomarker Assay Validation
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Implementing Best Practices for the Characterization of Critical Reagents
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