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Biosafety Testing

Biosafety Testing Service Overview

 

Along with our biologics development and manufacturing services, WuXi Biologics provides  biosafety testing as part of our integrated project platforms or as independent stand-alone services. Since 2015, WuXi Biologics has instituted EMA, ISO (CNAS), and CMA-certified laboratories in Suzhou, China and established a solid reputation in the industry for our biosafety services as confirmed through formal inspection from NMPA, EMA, and over 300 quality audits from global clients. As the largest biosafety testing provider in the Asia-Pacific region, we have continuously delivered an outstanding execution and compliance track record as demonstrated by zero rejections  from over 500 projects conducted and submitted to regulatory agencies worldwide.

 

Over 300 highly-trained scientists (~25% with international pharma/biopharma experience) work in conjunction with our efficient project management team to provide our clients with an unprecedented single-source service offering.


  • Our high-quality biosafety services include:
    • Cell Line Characterization
    • Bulk Lot Release Testing Services
    • Raw Material Release Test (Biosafety)
    • Viral Clearance Studies 

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

 

To support different submission needs from the U.S. FDA/EMA/JPMA/NMPA, WuXi Biologics’ Biosafety Team 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 largest single biosafety site in Asia, we offer 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/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 expedited timelines for these critical lot release tests.

 

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 client s better evaluate and reduce the risk from raw materials such as media, serums, or intermediates.

 

Biosafety test service we can provide

 

  • Sterility
  • Bioburden 
  • Mycoplasma
  • Animal-derived  adventitious virus testing 
     
    • 9CRF Porcine and Bovine test
    • PCR-based tests for specific viruses
      Examples:
        PVC I/PVC II
        BPyV

Viral Clearance studies are an essential part of the biologics manufacturing biosafety profile and is kept in consideration throughout the whole project development cycle, from pre-clinical development to BLA submission. At WuXi Biologics, we have a highly-trained and experienced viral clearance team with over 100 scientists. 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 400 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.  Project 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 our service experience through data mining. Using our experience from over 500 projects, we have established a database that enables us to help our customers predict the potential viral inactivation/removal rate in each purification step,   reduce redundant work,  decrease study time and costs.

Our facility is located in Suzhou China. The lab is approximately 4,000 square meters. The facility is separated into 25 client labs and equipped with 22 AKTATM Pure chromatography systems. As an example of our extensive capacity we are able to carry out 60 viral clearance projects per month and offer flexibility to our clients when dealing with schedule changes.

 

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.).