Meso Scale Discovery multiplex

Immunoassay Services for Drug Development: Accelerating Preclinical and Clinical Studies


Immunoassays such as the ELISA method and Meso Scale Discovery multiplex assays have become crucial for drug discovery and development. Applications of the ELISA assay method and other immunoassays are broad, ranging from pharmacokinetic analysis, biomarker assessment, and host cell protein impurity detection in release testing. ELISA peptide and Meso Scale Discovery assays are a crucial part of immunoassays for advancing emerging therapeutics such as nanobodies and recombinant proteins. 

The increased demand for biopharma R&D has accelerated the need for efficient methods such as ELISA analysis with the capability of delivering reliable and accurate results. These robust techniques are critical in instilling confidence in making data-driven decisions and meeting regulatory guidelines. Immunoassay services are increasingly being employed to develop bioanalytical assays that cost-effectively deliver precise and accurate data using minimum reagents and samples. These services are helping reduce operation times while generating meaningful data and reducing hands-on experimental time. The current article discusses the role of immunoassay services in accelerating preclinical and clinical studies. 

Accelerating drug development through reliable immunoassay services 

Experienced immunoassay services are well-versed in developing and validating a bioanalytical assay in a regulated experimental setting. They have an in-depth understanding of analytical science and statistical analysis to navigate complex regulatory requirements that exist today. These characteristics, combined with comprehensive project management and the availability of high throughput techniques and complex methods, have made immunoassay services a primary outsourcing partner.

Immunoassay service providers offer comprehensive support to develop and validate ligand-binding immunoassays to support the drug candidate through preclinical and clinical assessment. From immunogenicity testing and pharmacokinetic studies to biomarker evaluation, immunoassay services have a proven track record in conducting regulated bioanalysis. 

Immunoassay service providers have dedicated project managers who are the principal point of contact to manage expectations around study costs and timelines. All these project managers are scientists and researchers with experience in assay methodology. They play a crucial role in evaluating experimental data, communicating results, and recommending workflows during formal meetings. Project managers are trusted partners to help sponsors run projects smoothly and efficiently. 

Immunoassay service providers have extensive experience in method development. They can develop robust bioanalytical assays to support PK/PD assessment, BABE analysis, biomarker evaluation, and immunogenicity testing for novel therapeutic agents. Their method development scientist can help sponsors determine appropriate assay formats to meet the research needs of their bioanalytical product. Besides, all bioanalytical assays are designed to facilitate the efficient transition to subsequent method validation studies. 

The development and production team of immunoassay services work closely for a smooth translation of a bioanalytical assay from development to validation. Before beginning method validation, scientists at immunoassay service providers perform a comprehensive prevalidation experiment to confirm the reproducibility and reliability of the developed bioanalytical assay. They have an in-house characterization of critical reagents and cut-point statistical analysis. Moreover, most immunoassay service providers adopt a proactive approach to incorporate best regulatory practices and the latest technological advancement to ensure the project meets all regulatory and scientific requirements.

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