Structural characterization of biopharmaceuticals is critical to ensure product quality and lot-to-lot consistency throughout the entire product development lifecycle. The Mass Spectrometry Center of Excellence (MS CoE) at WuXi Biologics provides world leading mass spectrometry services for product quality attribute research, impurity identification and quantitation to support process development and optimization and product manufacture.
Using state-of-the-art instruments and leveraging the expertise of our mass spectrometry specialists, we provide analytical testing services for a wide range of molecular modalities, including, but not limited to, monoclonal and bispecific antibodies, fusion proteins, enzymes, other recombinant proteins including subunit vaccines, antibody drug conjugates (ADCs) and polypeptides. We have supported over 500 integrated DNA to IND projects, late-stage clinical programs and standalone analytical projects to date. As a trusted partner, we provide scientific expertise and technical solutions to our global pharmaceutical customers in order to efficiently advance their products into the clinic and beyond.
Our core business areas include:
- Structural characterization of therapeutic proteins in preclinical and clinical development as part of quality attribute studies
- Innovative MS method development focusing on qualitative and quantitative analysis of critical quality attributes (CQAs)
- Product and process-related impurity (e.g., host cell proteins) identification
- Peptide mapping method development for lot release testing
- Standalone project support throughout discovery and CMC development project phases
MS CoE offers full-service solutions customized for protein therapeutics at all stages of development from preclinical to licensure. Our mass spectrometry services include but not limited to the following: