Chemistry Manufacturing and Controls
From lead selection to large scale manufacturing the CMC team is involved at many stages in the development process of single domain antibody drugs
During lead selection the ‘developability’ of a drug candidate is carefully monitored to ensure stable and robust molecules enter pre-clinical and clinical development.
CMC experts will build on:
- Lead selection of the drug candidate
- Research and early clinical batch production up to 100g scale
- Formulation development for various drug presentations
- Developability studies
- Analytical development and characterization
- Host creation
- Upstream and downstream process development
- Technology transfer and upscaling at external CDMO
- Project management
Expression of single domain antibodies is commonly performed in microbial systems (Escherichia coli, Khomagatella phaffei Pichia pastoris) which have been proven to deliver highly efficient, high titer expression hosts that can be used in high density cell fermentations strategies. Platform technologies for process and analytical development expedite the development process delivering safe and stable drug products.