Development
Analytical Method Development and Services
- Wide range of molecular, biochemical and cell-based bioassays
- Comprehensive method development meeting USP, Ph. Eur., and FDA guidelines
- Expertise from discovery to cGxP therapeutic testing for all service types
Formulation Development Services
Fully integrated formulation development programs that emphasize critical quality attributes with ICH stabilities guidelines and manufacturability in mind.
Validate and Accelerate Your Compound
Commercial mindset from the start to accelerate timelines to clinic with:
- Upstream process development (USP) by optimizing cell productivity in single-use bioreactors (SUBs).
- Downstream process development (DSP)
- Performed for all protein-based technologies.
- Demonstrated success with purification schemes for hundreds of unique proteins for pre-clinical toxicology material.
CHO-GSN Platform Stable Cell Line Development Service
Our platform uses its proprietary cell line, custom stable expression vectors, and glutamine synthetase (GS) selection technology, maximizing purity and yield while minimizing the time between development and toxicology studies.
mRNA Development Services
End-to-end solutions covering mRNA synthesis, formulation and lipid nanoparticle fill-finish.