WuXi Biologics
Offering End-to-End Solutions
WuXi Biologics offers an extensive list of CMC (Chemistry, Manufacturing and Control) services that can be integrated and often conducted in parallel with our WuXiaTM cell line development services – all using the same cell line platform.
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 studies are availalbe 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.
Ten EMA-certified cGMP cell bank suites are available to produce approximately 160 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.
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 CLD activities.
WuXi Biologics’ molecular biology, cell biology and analytical laboratories work together to provide protein expression, product quality and stability assessments for research cell banks (RCB).
Comprehensive and wide-ranging analytical methods are available to assess the product during developability studies and cell line development. Examples include:
WuXi Biologics provides comprehensive one-stop cell banking and testing service compliant with global regulatory agencies. GMP cell bank facilities features include:
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