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Immunoassays for Pharmaceutical Development

Immunoassays are the technology of choice for many of the key bioanalytical challenges of drug development, and Fleet Bioprocessing Ltd. possess the immunoassay development knowhow to ensure that your custom assays are fit for purpose.

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Over the course of a typical drug development project, the reproducibility of critical reagents used in bioanalytical assays is key, and Fleet can help with this as well as developing robust assay methods. Dealing with issues arising from inconsistent conjugation methods for critical assay reagents has become a major issue for the industry, and a key source of delays. See our Bioconjugation pages and blog post for more information.

 

Typical immunoassay applications during pharma development include:

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Pharmacokinetic (PK) Immunoassays:

Monitoring the in vivo movement of a drug including its absorption, bioavailability, distribution, metabolism, and excretion.

Pharmacodynamic (PD) & Biomarker Immunoassays:

Monitoring the dose-dependent in vivo impact of the drug - often through the measurement of biomarkers which are indicative of desirable or undesirable drug effects.

Anti-Drug Antibody (ADA) & Other Immunogenicity Immunoassays:

Effectively a subset of PD monitoring the response of the human immune system to the drug, commonly to check for the generation of anti-drug antibodies which could interfere with drug action.

Companion Diagnostic Immunoassays

​Another application of immunoassays in the pharma sector arises from the rapidly-expanding field of theranostics, where the choice of drug is dependent on patient-specific results in a suitable companion diagnostic test.

 

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With the high-throughput needs of the pharma development market particularly in mind, Fleet is a Gyrolab Certified Assay Transfer and Development Partner, offering assay development, transfer and optimisation services for users of the Gyrolab platform.

Drug development and clinical trial process
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