Development

Analytical Method Development Services

  • Wide range of molecular, biochemical and cell-based bioassays
  • Comprehensive method development meeting USP, Ph. Eur., and FDA guidelines
  • Expertise from discovery to cGMP 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.

Accelerate Your Biologic

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) with purification schemes for hundreds of unique proteins for pre-clinical toxicology material
Biologics Development

Cell Line Development

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.