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Global Quality Control (Commercial and Late-Stage Clinical)

Our Quality Control (QC) team works closely with Manufacturing, Manufacturing Science and Technology (MSAT), Quality Assurance, and Analytical Science teams to provide our customers with high quality services in raw material, in-process control, product release , and stability testing for biologics products. We conducted over 900 method qualifications/verifications/transfers and over 110 method validations for various products  from 2017 to 2019. We have well-established analytical method life-cycle management procedures and capabilities, including method development/qualification/validation, and continuous method improvement and performance monitoring. We support projects from early clinical development through commercial manufacturing. 


Labs and Equipment

We currently have four QC labs in Wuxi, China  with more than 76,000 sq. ft. (7100 m2) of lab space in total. We are also establishing additional QC labs near other GMP manufacturing facilities throughout China, Germany, and Ireland. We have state-of-the-art instruments that benchmark industry standards and electronic systems including a Laboratory Information Management System (LIMS), Empower, extracellular matrix (ECM), MasterControl, and TrackWise.


Capabilities

We test over 200 release batches for drug substance and drug product annually.

 

Our in-process testing team works 24/7 to ensure real-time monitoring of manufacturing runs.

 

We test over 1,000 stability pull points annually.

 

We perform over 180 method qualifications/verifications/transfers and over 30 method validations annually.

 

We test and release over 1,000 batches of raw materials annually, including testing of clinical and commercial raw materials, excipients, media/feed, resins and packaging materials.

 

We perform routine environmental monitoring of over 9000 m2 clean rooms and zones for drug substances and drug products manufacturing.

 

We test over 16,000 CIP samples and 12,000 in-process control/testing samples annually.

 

We offer well-established reference standard (RS) characterization and test methods and RS program management that includes reference standard generation, qualification/requalification, inventory tracking and reference standard quality monitoring/trending on a routine basis. 

 

Stand-alone testing service is also provided. This covers full release/stability testing for biologics, testing for raw materials and packaging materials.