Assay Development Service

In today's clinical research environment, there is an increasing need for high quality tests to guide decisions. The development of robust and specific assays can be challenging. MSD's Assay Development Service offers a seamless process through which we will develop high-quality assays for your application. We have successfully collaborated with top biotech and pharmaceutical clients to develop assays ranging from immunoassays for secreted proteins and phosphoproteins to assays that measure protein-protein interactions, serology, and immunogenicity. Depending on your need, assays may be developed for basic research purposes or designed to include additional qualification and validation. Our personalized service includes regular progress updates on your project, interactive discussions on project status, and consultative decision making.

 

Key Benefits
  • Extensive assay development experience
  • Industry-leading technology platform
  • Single-analyte and multiplex assay development available
  • Personalized assay development and support every step of the way

 

Assay Development Stages

MSD follows a phase-gated and regulated process for assay development.

Feasibility
 
Development & Verification
 
Validation
  • Proof of concept assay development
  • Initial antibody selection and assay performance
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  • Delivers a fully developed assay
  • Testing for limits of detection, dynamic range, sample evaluation, and multiplex optimization (if applicable)
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  • Ensures delivery of an analytically validated product
  • Testing includes intra-plate, inter-plate, and inter-lot reproducibility

Our Quality Management System has received ISO 9001: 2008 certification for the design, development, manufacture, distribution and service of instruments, plates, reagents, assays and kits for research purposes.

Contact us to learn more about our Assay Development Service.

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