Scientific strategies and technical
solutions that advance Drug Development

Committed to customized scientific partnerships
to deliver life changing therapies

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

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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.

Group 2717

Bioanalytical Sciences

PK assays in support of large molecule, cell and gene therapy, and nucleic acid-based biotherapeutics

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Group 2695

Immunogenicity

ADA and NAb assays to support all biologic modalities, including C&GT and nucleic acid-based therapeutics

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microscope (5)

Cell based assays

Supporting neutralizing antibody, cell proliferation, potency and cell-based PK assays

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bar-graph (4)

Biomarker Sciences

Context of use driven de novo, multiplex, and commercial kit assays

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flask (1)

Critical Reagents

Critical reagent labeling and analytical characterization services

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dna (3)

Gene & Cell Therapy

Pharmaco/cellular kinetics, PD, safety, immunogenicity, biodistribution, expansion, persistence, cytokine analysis (CRS monitoring) and phenotypic analyses

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The Immunologix Difference

Strategic and Scientific Partnership for large molecule bioanalytical and biomarker sciences.

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Lab vials under blue light

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.

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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.

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Scientist at work
Scientist at work

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.

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Scientist viewing info on a monitor

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.

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A Customized Approach

Science-first strategies to meet your specific program needs

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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

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.

collaborate

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.

complete

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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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.”

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Read About Our Scientific Research

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Immunologix Laboratories: Advancing Immunogenicity Testing Through Collaboration and Innovation 

At Immunologix Laboratories, we’re committed to continually innovating in the field of…

Immunologix_Julia_Blog (1)

Overcoming Challenges in Bioanalytical Assay Development for Innovative Drug Modalities

Key Learnings The landscape of drug development is dynamic, and innovative drug…

Biomarker Assay Validation

Biomarker Assay Validation: Scientific Considerations As defined by the BeST glossary, a…

Talk To A Scientist

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