WuXi Biologics
Offering End-to-End Solutions
Cell Line Development
Proven, High-Yielding Cell Line Development Platform Accepted By Regulatory Agencies Worldwide
Whether the vaccine modality is a recombinant protein or viral-based, WuXi Vaccines provides mammalian cell line development as a stand-alone service or as part of an integrated early- or late-stage CMC (Chemistry, Manufacturing and Control) program.
Sequence Analysis
Our team of experts use sequence analysis and Artificial Intelligence (AI)-assisted codon optimization to design out undesirable product quality attributes. In addition, Next Generation Sequencing (NGS)-guided clone screening is available.
Developability
Developability studies are available to determine if the product fits to upstream and downstream processes while also obtaining product and formulation stability data. These studies are ideal if evaluating multiple product variants to choose the eventual lead molecule.
GMP Cell Banking and Cell Line Characterization
We provide EMA- approved GMP cell banks suites for use in vaccine programs. 21 cGMP cell bank suites are available to produce over 300 Master Cell Banks (MCB) and Working Cell Banks (WCB) per year. Comprehensive in-house cell line characterization services performed per global regulatory guidelines (e.g ICH, U.S. FDA, EMA and NMPA) are also available to provide streamlined, efficient one-stop service from cell line development to release of GMP manufactured cell banks.
Process Development
Integrated with the cell line development program, we have established one of the world’s largest and most experienced process development teams to develop, optimize and validate upstream and downstream processes for eventual large-scale GMP manufacture using the same cell line platform used during all Cell Line Development (CLD) activities.
Long-term Productivity and Genetic Stability Study
WuXi Vaccines’ molecular biology, cell biology and analytical laboratories work together to provide expression, product quality and stability assessments for research cell banks (RCBs), MCBs, WCBs and End of production cell banks (EOPCBs).
Analytical Services
Comprehensive and wide-ranging analytical methods are available to assess the vaccine during developability studies and cell line development. Examples include:
- Purity
- Aggregates
- Identity
- Titer
- Glycan Profile
- Binding or Potency Assay
- Charge Variance
- Sequence Variance
- Post-Translational Modifications
- Particle Size
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