Custom Protein Generation

Drug Substance Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

 

WuXi Biologics provides extensive capacity to manufacture Master Cell Banks [MCB], Working Cell Banks [WCB] and End of Production Cell [EOPC] Banks that meet worldwide cGMP regulatory standards and guidelines (ICH, U.S. FDA, EMA, and NMPA). Integrated with the manufacture of the cell banks is comprehensive in-house biosafety and cell line characterization services, thus offering a streamlined and efficient timeline from vial thaw to Quality Assurance cell bank release. In addition, WuXi Biologics offers cell line engineering services providing a single-source, one-stop approach for biologics cell line CMC development.

 

GMP Cell Bank Generation and Capacity

  • Cell bank facility audited and approved by EMA for GMP manufacture
  • 10 independent suites run on a campaign basis
  • Up to 150 GMP cell banks can be generated per year
  • Automated filling system allows up to 1,000 vials/bank.
  • Highly trained staff qualified in aseptic techniques
  • Long-term GMP cell bank storage available in two locations (Shanghai and Wuxi)
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Cell Line Characterization (CLC)

WuXi Biologics offers exceptional technical and regulatory expertise and dedicated in-house virology, molecular biology, cell biology, in-life and microbiology labs to provide high-quality and comprehensive CLC services.  ICH and NMPA (previously CFDA) guidelines. The methods we use are harmonized with global standards (e.g. ICH, EP, USP, JP, CN). As successful characterization of cell banks has many essential elements, including identity and detection of micro-organisms, mycoplasma and adventitious virus, a wide-range of test methods are utilized.  See the table below as an example of the tests available for a typical CHO cell line characterization package.

Authenticity and Species Identity
  • Cell Morphology observation
  • Cell line identity
Microbial Contamination
  • Sterlity Testing
  • Mycoplasma Detection
    • Direct and indirect culture-based test
    • PCR-based method
General Adventitious Virus Screens
  • In vitro test
  • in vivo test
Species Specific Virus Detection
  • HAP test
  • Detection of Minute Virus of Mouse (MVM) via qPCR method
  • Optional but recommended: Detection of Calicivirus via qPCR method
Retrovirus Detection
  • Transmission Electron Microscopy (TEM)
  • Co-cultivation S+L- Test
  • Reverse Transcriptase (RT) activity
Adventitious Viruses from Animal-Derived Raw Material Detection
  • Porcine virus detection
    • 9CFR-based method
    • (Optional but recommended): qPCR method for specific viruses (e.g., porcine circovirus)
  • Bovine virus detection
    • 9CFR-based method
    • (Optional but recommended): qPCR method for specific viruses (e.g., bovine polyoma virus)

WuXi Biologics’ cell line biosafety and characterization testing facilities are located in Suzhou and Shanghai, China. As the first non-state affiliated lab of its type in China and Asia, WuXi Biologics is one of the rare CDMOs that offer in-house biosafety testing capabilities. These capabilities allow WuXi Biologics to streamline development timelines because we eliminate the problematic hand-offs inherent in the historic multiple vendor model. If using our standard cell line, cell culture and purification technology platforms these development timelines can be reduced even further.

For information on our proprietary WuXia CHO K1
cell line development platform –
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Genetic Stability Studies

Utilizing a combination of state-of-the-art molecular biology, nucleic acid amplification and next-generation sequencing (NGS) techniques, WuXi Biologics, has developed proprietary methods that allow for fast, sensitive, high throughput and cost-saving cell line characterization studies that are applicable for both pre-IND and late stage regulatory filing purposes.

Services include:

  • Clonality analysis
  • Copy number determination
  • Determination of integration site(s)
  • Transgene integrity (genetic variations in DNA and RNA)

 

Cell Line Clonality and Case Study

WuXi Biologics utilizes its proprietary and state-of-art nucleic acid amplification and NGS method for clonality determination. Advantages of our method and a comparison to traditional clonality methodologies is provided in the Case Study below.

Background

Client asked WuXi Biologics to prove the clonality of their lead cell line (Chinese Hamster Ovary (CHO) cells) for inclusion in the client’s IND CMC dossier. Failing to provide this information could lead to a significant delay for IND approval. Expedited timelines were requested by client to complete the analysis in time for the IND filing.

Challenge

Conventional methods for clonality determination (FISH or Southern Blot methods) are slow, labor intensive and technically demanding. In addition, potential CHO cell genetic instability can interfere with these conventional methods, resulting in clonal cell lines to be judged as non-clonal. See Table 1 for comparison of methods.

Solution/Results

WuXi Biologics utilized its proprietary and state-of-art nucleic acid amplification and NGS method for clonality determination. Client timelines were met for IND filing and the IND was successfully granted by the regulatory agency.

 

Table 1. Clonality Method Comparison

Fish Southern Blot NGS and PCR fingerprinting (WuXi Biologics proprietary method)
High-throughput No No Yes
Sensitivity Medium Medium High
Interference by genetic instability

(generating a false negative)

High High Low
Labor High High Low
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