Biosafety Testing

A contamination-free cell bank is not only fundamental for biologics production, but is also requested by the regulatory authorities. WuXi Biologics provides comprehensive cell line characterization services for Master Cell Bank (MCB), Working Cell Bank (WCB) and End of Production Cells (EoPC/CAL) for mammalian (e.g., CHO and HEK293) and microbial cell lines.

To support different submission needs from the various global regulatory authorities (e.g., U.S. FDA, EMA, JPMA, NMPA), WuXi Biologics’ Biosafety Team of experts will help you generate a proper characterization panel through our qualified pharmacopeia methods (USP/EP/JP/ChP) and other validated in-house methods that follow ICH, U.S. FDA Points to Consider guidelines and other similar global regulatory guidances. Moreover, as the leading biosafety site in Asia, we offer fast testing turn-around-times and significant capacity for delivering results per client expectations. Because of our extensive capacities, we are able to customize and accelerate testing programs based on project timelines and needs. Strong collaboration between the WuXi Biologics development and manufacturing departments via our project management systems help ensures successful project execution and delivery of results per mutually agreed upon timelines and milestones.

Each batch of cell harvest material or unprocessed bulk (UBP) must be tested for the presence of adventitious virus and mycoplasma as per ICH Q5A and other similar global regulatory guidance documents. WuXi Biologics offers in vitro and molecular biology (qPCR) approaches and the applicable USP, EP, JP and ChP methods, under GLP and GMP standards for detection of these microorganisms. We have streamlined the testing, reporting, and Quality Assurance processes to provide fast testing and report generation timelines for these critical lot release tests.

We also provide a highly-trained team of scientists dedicated to commercial product lot release. Over 15 commercial products have been tested in our GMP biosafety testing laboratories and we offer expedited turn-around-times (TAT) to ensure we meet your manufacturing release timelines.

Our experts are able to discuss and verify project-based test items with you – please contact us if you have any questions.

When animal-derived materials are used in the development of cell lines or in the manufacturing process, they inherently increase the risk of adventitious virus contamination. WuXi Biologics biosafety lab offers a series of tests to help our clients better evaluate and reduce the risk from raw materials such as media, serums, or other raw material intermediates.

Biosafety tests we provide:

• Sterility
• Bioburden 
• Mycoplasma
• Animal-derived in vitro adventitious virus testing 
   

• • 9CRF Porcine and Bovine test
  • PCR-based tests for specific viruses
    Examples (but not limited too):
      PCV I/PCV II
      BPyV

Viral clearance (VC) and viral inactivation studies are an essential part of the biologics manufacturing biosafety profile. Viral clearance is a critical consideration throughout the whole project development cycle, from pre-clinical activities to BLA submission. At WuXi Biologics, we have a highly-trained and experienced viral clearance team with hundreds of scientists with the capacity to conduct over 10 VC studies per week.

This world-class team helps our clients design the viral clearance protocol and align it with the downstream purification scheme and regulatory submission needs. Since 2015, we have conducted over 600 projects with a variety of product types and successfully filed with the U.S. FDA, EMA,  NMPA,  JPMA, or TGA for IND or BLA submissions.  Product type experience includes:

• Monoclonal antibodies
• Bispecific antibodies
• Fusion proteins
• Recombinant proteins
• Peptide products

As a leading viral clearance service provider, we are keen to improve your project and knowledge of your purification processes through data mining. Using our experience from over 600 projects, we have established a database that enables us to help you predict the potential viral inactivation/removal rate in each purification step, reduce redundant work, decrease study time and reduce project costs.

We operate two facilities located in Suzhou, China. With approximately 16,000 square meters of facility space and multiple testing laboratories and viral clearance suites, we provide extensive capacity to start projects quickly and adapt to schedule changes to help meet your deadlines. As an example of our extensive capacity we are able to carry out 10 viral clearance projects per week and test over 400 cell banks and provide QC release to over 900 UPB lots per year. 

From a quality perspective, the Suzhou biosafety laboratory is BSL-2, ISO 17025/CNAS and CMA-certified, and all the services meet international regulatory considerations and standards (e.g., ICH, U.S FDA, EMA NMPA etc.).