Working on CDMO for Macromolecular Target Drugs
Proceeding from the scientific evidence and platform experience, we perform physical and chemical analysis, biochemical study, and activity analysis by applying Pharmacopeia and approaches that were developed and validated by ourselves to explore the stability of the preparation.
◆ We provide stability test and storage protocol design services and have all required conditions in ICH guidelines; establish and validate stability testing methods according to ICH standards to meet the various requirements at home and abroad;
◆ Professional team is in change of the management of stability items, and provides unified and standardized management specification and high implementation standards for all projects based on the stability SOP and protocol;
◆ In addition to routine stability protocol, the customized stability protocol can accurately confirm the expiry date of product to meet the needs of clients’ clinical studies and product quality monitoring.