Validation and Method Development

Method development, validation and transfer are essential but often overlooked elements of traditional pharmaceutical and biological development. For small molecule projects, we often help source reference and internal standards. Our team can act as an extension of your organization through method development, qualification and validation.

For large molecules, we know things don’t often go as planned with biological assays. We can help in any number of ways, from troubleshooting assay experiments to critical reagent generation, development and confirmation of assay platforms, biomarkers for PD or immunogenicity (anti-drug antibody) platforms. Our expertise is broad, and we can be as high-level or as hands-on as you require.

Whether your program involves large molecule, small molecule or biomarkers, our services help ensure regulatory compliance.

In partnership with PPD, we explored the feasibility of single-well analysis over duplicate-well analysis. The study with less variable populations yielded equivalent results for singlet analysis as for duplicate-well analysis for cut point determination.

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Contact us today and let us know what challenges you are facing.