WuXi Biologics
Offering End-to-End Solutions
Cell Line Development
Proven, High-Yielding Cell Line Development Accepted by Regulatory Agencies Worldwide
Whether a product modality is an antibody, recombinant protein vaccine, or viral-based vaccine, WuXi Vaccines provides mammalian cell line development as a stand-alone service or as part of an integrated early- or late-stage CMC program. Our offerings include expert guidance, vetted cell line technology, and efficient development timelines. Sequencers join extensive analytical and process development support to accelerate your project into the clinic and beyond.
Sequence Analysis
Our team of experts use sequence analysis and codon optimization to eliminate undesirable product attributes. Next generation sequencing (NGS)-guided clone screening is also available.
Developability
Developability studies are available to determine whether a product fits upstream and downstream processes while also obtaining product and formulation stability data. These studies are ideal for evaluating multiple product variants to choose an eventual lead molecule.
GMP Cell Banking and Cell Line Characterization
We provide EMA-approved GMP cell banks suites for use in vaccine and prophylactic antibody programs. Twenty-one cGMP cell bank suites are available to produce over 300 master cell banks (MCBs) and working cell banks (WCB) per year.
Comprehensive cell line characterization performed per global regulatory guidelines (e.g ICH, U.S. FDA, EMA and NMPA) is also available to provide a streamlined, efficient, single-source service from cell line development to the 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 for cell line development (CLD).
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 and antibody during developability studies and cell line development, such as:
- Purity
- Aggregates
- Identity
- Titer
- Glycan Profile
- Binding or Potency Assay
- Charge Variance
- Sequence Variance
- Post-Translational Modifications
- Particle Size
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