We offer both complete Analytical development services and stand-alone services for protein therapeutics. The analytical team offers strong scientific knowledge coupled with technical expertise in method development, qualification and validation for a wide range of analytical tests for biotherapeutics.

In addition to development and qualification, the analytical team also offers method validation as per ICH (Q2R1) guidelines. Our services include development of analytical methods for lot-release, in-process testing, stability testing and impurity characterization.

The method development services that we currently offer include:

• Chromatographic testing for determining purity and quantity using RP-HPLC, SEC-HPLC, IE-HPLC etc.
• Peptide mapping by RP-HPLC
• Electrophoresis-based methods like SDS-PAGE (1D and 2D), IEF, Western Blotting, gradient gel electrophoresis, tricine gel electrophoresis etc.
• Capillary Zone Electrophoresis
• Protein quantification