Global Quality Control (QC)

Quality control supports analytical development teams with technical transfer and assay verification when applicable and provides phase appropriate assay specification setting, qualification and validation activities for in-process / in-line, release and stability methods. We have performed over 5,300 early-stage method qualifications and conducted over 370  late-stage method validations since beginning QC operations.

Our dedicated team supports the setting of cell bank specifications and coordinates the testing and release of over 160 cell banks (e.g., Master Cell Banks (MCB), Manufacturer’s Working Cell Banks (MWCB / WCB) and End of Production Cell Banks (EOPCs)) on an annual basis.  These cell banks are used in the production of a wide array of biologics and vaccines. Release testing includes testing for adventitious agents, identity and growth characteristics per the guidelines established by the ICH and other global regulatory agencies. For more information on our comprehensive biosafety testing services – click here.

Our Raw Materials (RM) controls and testing team supports over 3,400 lots annually. These comprehensive in-house RM labs test a wide array of raw materials such as chemicals, buffers, excipients, media, supplements, resins and packaging material.  The team conducts complete specifications setting, testing and release of materials used for clinical and commercial manufacturing.

To help ensure consistent GMP manufacture, reduce variability and identify problems during production runs our QC teams support the establishment, testing and validation (when relevant) of in-process controls. Our QC testing teams work 7 days a week, 24 hours a day to perform real-time monitoring of the various manufacturing processes to determine if in-process samples meet the established in-process control specifications.  This critical function helps ensure product consistency, reliability, quality, safety, and efficacy.  

WuXi Biologics analytical and biosafety testing laboratories can perform in-house all the testing required from the cell harvest or unprocessed bulk (UPB) material generated within bioreactors during biologics manufacturing including the critical adventitious agents testing (for more information on our biosafety testing capabilities – click here).  We test over 1,000 UPB lots per year under GMP conditions.

• • In vitro viral assay screen for the presence of endogenous and adventitious virus
  • Mycoplasma per the harmonized pharmacopeia methods
  • Sterility or microbial enumeration
  • Product titer, identity, purity, and concentration (as applicable)

Regardless the type of biologic or vaccine, and utilizing an extensive network of analytical, bioassay, biosafety, microbiology, molecular biology, physicochemistry and immunology laboratories our QC teams have extensive experience in the support of assay transfer, qualification and validation and routine batch testing. Our in-house, state-of-the-art labs perform release testing for over 1,000 clinical and commercial DS and DP lots annually under GMP conditions.  

We provide a protocol-driven stability program integrated with our LIMS platform for scheduling stability pull-points, sample testing and tracking. Over 400 stability lots are managed by QC annually.  We maintain a vast number of storage units and facilities and all stability storage settings (temperature and humidity) are maintained per ICH guidelines. Photostability stability programs are also available at multiple sites around the globe. 

QC supports analytical development and GMP operations in the performance of comparability studies that are conducted to understand the impact on the quality and safety of the drug substance or drug product resulting from a change in raw materials or the manufacturing process.  Similarly, QC tests samples to verify the product is of the same quality and consistency from batch to batch during late-stage process validation and conformance batch runs. Additionally, these critical studies, including post-market studies, provide evidence that the product properties remain unchanged throughout the drug‘s shelf life.

Purpose built to support our global QC functions, our LIMS platform begins in the warehouse with raw material receipt and integrates all downstream functions throughout testing of raw materials, EM and in-process samples, controls/reference standards, release and stability of drug substance and drug product and final report or Certificate of Analysis (CoA) review.  Our LIMS system has withstood scrutiny from over 25 regulatory agency inspections and 800+ client quality audits.

In addition to the LIMS, other electronic/software platforms, such as CISPro inventory management and Laboratory Execution System (LES) are also utilized in some sites.

We routinely perform method transfers, verifications and qualifications for every client project. We then provide late-stage method validation and maintain a comprehensive method life-cycle management program for the validated assays. The life-cycle management program includes trend analysis on assay performance to ensure robustness for all QC-related assays and methods.

Our Environment and Utility Monitoring (EM) performs routine environmental monitoring in-house for all GMP Cell Banking, Drug Substance (DS), Drug Product (DP) and QC laboratories that includes surface, air, process gas and water system samples. We perform routine EM of our >100,000 m² clean rooms and zones in our sites globally.  Routine analysis includes testing for surface microbes, settling microbes, airborne microbes and airborne particles.

QC supports IQ/OQ/PQ, calibration and maintenance aspects of the quality assurance equipment life-cycle management (ELCM) program and provides ongoing equipment / instrument monitoring to ensure all equipment used in the QC laboratories remain accurate, reliable, consistent and safe and functioning per its intended use.  In addition, most QC equipment is harmonized with our analytical development labs for efficient assay transfer into quality control. 

WuXi Biologics’ global quality function hosts many quality system inspections per year from either regulatory agencies (e.g., U.S. FDA, EMA, NMPA, etc.), Quality Persons or our client’s compliance / audit teams.  QC supports our quality unit in all inspections / audits and together we have successfully passed over 25 regulatory inspections from multiple different global regulatory agencies and over 800 client quality audits since establishing our quality operations in 2014. We use ALCOA data integrity principles and to date, there have been no findings regarding data integrity at any of our sites around the world.

QC works closely with Quality Assurance and GMP Operations to provide ongoing management and storage of all raw materials, in-process and production batch testing samples and retains involved with or generated during GMP manufacturing.  All sample / retain samples are stored per established specifications in qualified or validated storage units as applicable.  The comprehensive sample / retain storage and disposal procedures are reviewed with our clients and communication procedures are reviewed periodically with current and past clients prior to disposal of any samples / retains generated in client projects.  Typical storage conditions available include: 

-80°C ± 10°C;  -70°C ± 10°C; -60°C ± 10°C; -40°C ± 5°C; -20°C ± 5°C; 5°C ± 3°C

We offer well-established reference standard (RS) characterization and test methods and RS program management that includes reference standard generation, qualification/requalification, storage and inventory tracking and reference standard quality monitoring, stability and trending on a routine basis for over 400 reference standards on an annual basis.