Scil Proteins Production provides Contract Development and Contract Manufacturing services for cGMP and non-GMP projects with microbial expression hosts.
Contract Development Services:- Cell line design
- Fermentation development (batch/fed-batch)
- Refolding development
- Downstream process (DSP) development
- Development of analytical methods
- PEGylation development
Contract Manufacturing Services non-GMP:- Feasibility studies
- Production of protein material for preclinical studies and diagnostics
- Production of proteins material for regulatory toxicology studies
Contract Manufacturing Services cGMP:
- Tech transfer and scale-up
- Production of clinical trial protein API (Phase I - III)
- Production of protein API for market supply
- Process validation
- Analytical method validation
- API release
Further Services:- Regulatory support and dossier generation
- Project management
- Stability studies according ICH guidelines
- Reference standard generation and characterisation
- Quality management for both non-GMP and cGMP services
