WuXia™ Cell Line Development (V2)

Our Host Cell Toolbox Enables Fit for Purpose Development

In addition to our CHO-K1, HEK293, Fut8KO and GS CHO host cell lines, we provide gene editing services using our in-house CRISPR- guided RNA design tool and highly optimized and engineered host cell genome to further improve performance.

Learn more at the following links:

• CRISPR Gene Editing Services
• Protein Sciences Cell Engineering

Proprietary In-Silico Toolbox  – Metadata Codon Optimization

We offer a collection of in silico protein molecule assessment, design and optimization tools, which include sequence liability and signal peptide analysis, and post-translational modification, immunogenicity and aggregation prediction.

Learn more at the following links:

• Protein Sciences Bioinformatics

Rapid Bulk Pool Enables Fast Material Generation for Development and Toxicology and Clinical studies.

Post transfection into our host cell line, we rapidly generate bulk pools for initial screening prior to single cell clone selection. Our Rapid Bulk Pool process is also used to quickly produce high quantity and high quality product for development and toxicology studies.

Lab Digitalization and Automation Ensure Development Quality

The WuXi Biologics CLD team utilizes multiple high-throughput automated equipment and systems throughout the cell line development process. Lab digitalization systems (e.g., LDMS) and automation helps ensure cell line and product quality through robust and reproducible sample handling and processing.

Exceptional Stability

Our WuXia CHO-K1 platform provides highly stable clones for large scale commercial manufacturing. The proof of the robustness of our host cell line comes from cell line and product stability studies conducted on over 300+ producer cell lines generated for clinical and commercial production.

Reagent and Bioassay Cell Lines to support Analytical Programs

In addition to biotherapeutic production cell line development services, WuXi Biologics’ CLD team generates cell lines for protein reagent production and bioassay cell lines to support analytical programs throughout development and into GMP quality control testing.

Standard Process for Reagent & Research Cell Line Generation

Specialized NGS & Molecular Biology Services

WuXi Biologics offers a wide range of Next Generation Sequencing and other critical molecular biology methodologies for the evaluation of cell lines and the gene of interest either in support of an integrated CLD program or as a standalone service.

Deep Sequencing of Cell Lines via NGS

Comprehensive and wide-ranging analytical methods are available to assess the product during developability studies and cell line development activities. Examples of our analytical services that support CLD include:

• Purity
• Aggregates
• Identity
• Titer
• Glycan Profile
• Binding or Potency Assay
• Charge Variance
• Sequence Variance
• Post-Translational Modifications 

Our in silico assessment toolbox was designed for clients evaluating multiple lead molecule candidates to make economical and efficient CMC product development decisions. This in silico analysis could predict and mitigate the risks of subsequent development issues due to manufacturability, stability, immunogenicity and other issues.  These in silico services can be integrated into a CLD program or provided to you as a customized standalone service.

Our in silico assessment contains three core-aspects:

1. Sequence analysis
2. Aggregation propensity
3. Determination of immunogenicity

For sequence analysis, we first check the sequence elements and identify the unknown domain/motif. Then, we verify if there are any sequence areas (“hot spots”) that could potentially be  susceptible to chemical and enzymatic modifications.

For aggregation propensity, we calculate the aggregation probability based on the surface hydrophobicity, charge, and free-cysteine residues of the protein.

Lastly, we evaluate the immunogenicity risk of the molecule by computing the sequence binding possibility to MHC molecules, and also comparing the sequence similarity to the human BCR database.

Through in silico assessment, the molecule candidates with higher CMC risks could be eliminated from further development to save cost and ensure development timeline milestones are met. Below we provide typical data or analysis resulting from our in silico biomolecule assessment program.

One-stop Cell Bank Creation

WuXi Biologics’ Suzhou biosafety testing lab is the leading biosafety lab in the Asia Pacific (APAC) region. We provide comprehensive, validated methods that meet global regulatory guidelines (e.g, USP/EP/JP/ChP and ICH, U.S. FDA, EMA and NMPA). Services include:

• Cell line characterization (PCB/MCB/WCB/EOPC )
• Mycoplasma, general virus and adventitious virus assays for various biologics, and cell and gene therapies.
• Viral clearance validation studies for IND and BLA.
• Clinical and commercial Unprocessed Bulk (UPB) lot release services.

More information about Suzhou Biosafety Testing Click here. 

The need to evaluate genetic stability of clonal cell lines with multiple chromosomal insertions of an expression construct and used for biologics production is dictated by the global regulatory agencies.  The recommendations could include verification of nucleotide sequence by directional sequencing of the mRNA or cDNA, Southern and/or northern blotting, and determination of copy number by qPCR or ddPCR amongst other possible criteria.

We provide a one-stop all-inclusive genetic stability evaluation of Master Cell Banks (MCBs), Working Cell Banks (WCBs) and End of Production Cells (EOPC) either integrated into a cell line development project or as a customized standalone service. Our molecular biology team has successfully completed genetic stability studies for our global clients in >140 IND applications and >40 BLA filings.

WuXi Biologics Customized Genetic Stability Services