Laboratory Services and Scientific Strategies that advance Drug Development

Committed to customized scientific partnerships
to deliver life changing therapies

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.

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Bioanalytical Sciences

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

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Immunogenicity

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

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Cell based assays

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

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Biomarker Sciences

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

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Critical Reagents

Critical reagent labeling and analytical characterization services

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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.

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.

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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.

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.

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Integrated Team

Translational Sciences - Integrated drug development and laboratory sciences expertise

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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.

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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.

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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.”