We offer a full spectrum of structural and functional analytical service to support the development and manufacturing lifecycle
Our protein science group offers a full spectrum of protein science research services. The analytical development team is responsible for DS and DP release as well as in-process analytical method development, transfer, optimization, qualification and validation. We adopt stage-wise validation strategy throughout the development lifecycle, as per recommended by ICH and other global regulatory guidelines. .
We offer reliable and comprehensive analytical method for both physio-chemical and biological characterization to support the development and manufacturing of your product. Our broad range of analytical services and capabilities are imperative for successful project outcome, which provide robust and thorough characterizations of relevant target protein quality attributes at various stages of the development, including reference standard and degradants characterization, as well as demonstrating product comparability.
We also have experience in developing DP formulation for clinical applications with a phase-appropriate manner to provide all necessary know-how supporting successful development and manufacturing of your products.