Analytical Method Transfer & Development

Method transfer

Cytovance can perform analytical method transfer no matter what stage of development is currently in place: Partially-Developed Assays: transfer partially-developed assays not found suitable for validation/qualified according to ICH Q2R1 guidelines. Cytovance will attempt to reproduce client data; based on the obtained results, Cytovance will recommend a Scope of Work for further method optimization/development.

Fully-Developed Assays: transfer fully-developed methods found suitable for validation/qualified according to ICH Q2R1 guidelines. Verify methods are suitable for validation/qualification.

Validated/Qualified Assays: transfer validated/qualified methods to Cytovance. Verification of validation/ qualification parameters will remain applicable by satisfying USP Transfer of Analytical Procedures.

Method Development

Cytovance development will work with you to develop robust analytical methods for product-specific analysis. Our Analytical Development team will work with each customer to determine the most appropriate set of methods based on customer preference, product physiochemical properties, and Cytovance’s experience with similar products

Partially-Developed Assays

Transfer partially-developed assays not found suitable for validation/qualified according ICH Q2R1 guidelines. Cytovance will attempt to reproduce client data; based on the obtained results, Cytovance will recommend a Scope of Work for further method optimization/development.

Fully-Developed Assays (No Optimization Required)

Transfer fully-developed methods found suitable for validation/qualified according to ICH Q2R1 guidelines. Verify methods are suitable for validation/qualification.

Validated/Qualified Assays

Transfer validated/qualified methods to Cytovance. Verification of validation/ qualification parameters will remain applicable by satisfying USP <1224> Transfer of Analytical Procedures.