About Immunologix Laboratories

Immunologix Laboratories is a unique scientific partner, offering GLP and GCP compliant laboratory capabilities focused on ligand binding-based bioanalysis coupled with expert scientific consultation from our Translational Sciences team.

Our laboratory specializes in Immunogenicity, Neutralizing Antibody (cell-based and ligand binding based), PK, and Biomarker assays in support of preclinical and clinical studies. Translational Sciences provides dedicated scientific resources to advise, develop and implement scientific strategies and practical solutions for innovator development programs. Our fully customizable approach includes delivering stage-appropriate biomarker & bioanalytical strategies, assay development and validation, study data interpretation, and support for regulatory interactions and filings.

Our exceptional scientific experts work together as an integrated team ensuring that our client’s projects receive full benefit of the breadth and depth of experience gained over many decades within both contract laboratory and drug development organizations. The integration of Translational Sciences with the laboratory is unique within our industry and this confluence of expertise enables our team to deliver valuable scientific insights that accelerate decision making and the course of drug development.

Please contact us at [email protected]

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Website
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Employees
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Industry
Biotechnology Research
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Headquarter
4710 Eisenhower Blvd, Tampa, Florida 33634, US
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Founded
2012
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Keywords
Translational Science, Regulated Bioanalysis, Immunoassay Method Development And Validation, Immunogenicity Assays, Pk Immunoassays, Biomarker Assay Sciences

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Frequently Asked Questions about Immunologix Laboratories

Who are the decision makers in Immunologix Laboratories?

The decision makers in Immunologix Laboratories are Chris Stebbins, Devangi Mehta, Jason Ambrosius, etc. Click to Find Immunologix Laboratories decision makers emails.

What types of bioanalytical services does Immunologix Laboratories offer?

Immunologix Laboratories specializes in ligand binding-based bioanalysis, providing a range of services including immunoassay method development and validation, immunogenicity assays, pharmacokinetic (PK) immunoassays, and biomarker assay sciences. Our laboratory capabilities are compliant with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards, ensuring high-quality and reliable results for our clients.

How does Immunologix Laboratories support the pharmaceutical and biotech industries?

Immunologix Laboratories serves as a scientific partner for pharmaceutical and biotech companies by offering expert consultation and comprehensive bioanalytical services. Our Translational Sciences team collaborates closely with clients to design and implement studies that meet regulatory requirements, facilitating the development of therapeutics from preclinical stages through clinical trials. We aim to streamline the drug development process and enhance the success rate of new therapies.

What is the process for developing and validating an immunoassay at Immunologix Laboratories?

The process for developing and validating an immunoassay at Immunologix Laboratories begins with a thorough assessment of the client's requirements and the specific analyte of interest. Our team then designs the assay, optimizing conditions to ensure sensitivity, specificity, and reproducibility. Once the assay is developed, it undergoes rigorous validation according to GLP and GCP standards, including assessments of accuracy, precision, linearity, and stability. We provide comprehensive documentation throughout the process to support regulatory submissions.

Can Immunologix Laboratories assist with biomarker discovery and validation?

Yes, Immunologix Laboratories offers services in biomarker assay sciences, which include biomarker discovery, development, and validation. Our team employs advanced techniques and methodologies to identify potential biomarkers that can be used for patient stratification, disease monitoring, and therapeutic efficacy assessment. We work closely with clients to ensure that the biomarker assays are robust, reproducible, and suitable for their specific research or clinical needs.

What are immunogenicity assays, and why are they important?

Immunogenicity assays are critical tests that evaluate the immune response to therapeutic proteins, including monoclonal antibodies and vaccines. These assays help determine whether a therapeutic agent elicits an unwanted immune response that could affect its safety and efficacy. At Immunologix Laboratories, we conduct comprehensive immunogenicity assessments to support our clients in understanding the immunological profile of their products, ensuring compliance with regulatory expectations and enhancing the overall development strategy.

How can I get in touch with Immunologix Laboratories for a consultation?

To get in touch with Immunologix Laboratories for a consultation, you can visit our website at http://www.immunologixlabs.com and fill out the contact form provided. Alternatively, you can reach us directly via email or phone, both of which are listed on our contact page. Our team is ready to discuss your specific needs and how we can support your research and development efforts.

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