Your partner in science for end-to-end CRDMO solutions
Analytical Development
Jubilant Biosys has highly experienced team of analytical specialists to ensure all the analytical needs are met. This includes methods to support raw material release, in process/intermediate testing and final product analysis.
- All methods are developed with cGMP quality and are suitable for validation at the appropriate phase.
- We follow relevant ICH guidelines such as ICH Q2 (R1) or Pharmacopoeial methods/compendia guidance in combination with client-specific protocols.
- Analytical method validation (a protocol-guided activity) ensures that a test procedure is accurate, reproducible, and sensitive within a specified range based on the application of the method.
- Through close evaluation of performance characteristics against pre-approved acceptance criteria, analytical method validation assesses an analytical method to demonstrate its suitability for the intended purpose.
Method Validation Process
