We provide integrated CDMO programs across Pharmaceutical Development & Manufacturing and Drug Substance Development. We align molecular attributes with fit-for-purpose CMC strategies, uniting expression, purification, analytics, and preformulation into coherent development plans.
Overview of Therapeutic Protein Development
Therapeutic protein development requires synchronized control of sequence liabilities, process parameters, and material attributes. Early assessments examine chemical and physical stability, glycan profiles, charge variants, and higher-order structure to define critical quality attributes and set acceptance criteria. Upstream development balances expression, folding, redox, and secretion constraints; downstream schemes apply orthogonal capture and polishing to separate near neighbors and minimize product-related variants. Analytical strategies employ complementary methods—mass spectrometry, electrophoretic techniques, chromatographic separations, biophysical probes, and potency readouts—to verify identity, purity, and function. The outcome is a de-risked, class-aware control strategy that supports reliable drug-substance generation and stable in-use performance.
Our Services
We deliver four class-specific development services under a unified, phase-appropriate CMC framework. Each program integrates upstream optimization, orthogonal purification, stability-indicating analytics, and preformulation science.
We provide class-aware CDMO development for insulin, hormone protein, enzyme, and cytokine, integrating platformable processes, orthogonal analytics, and stability-focused formulation. Contact us to scope a tailored development plan.
Frequently Asked Questions
Q1: How do you choose an expression system for different therapeutic proteins?
We match host biology to the molecule's liabilities and target quality profile.
- Insulin/short peptides: Microbial hosts with inclusion-body capture, controlled refolding, and enzymatic pro-segment processing to ensure correct disulfide pairing and isoform resolution.
- Hormone proteins requiring human-like glycans (e.g., EPO): Mammalian expression to manage sialylation and reduce high-mannose species; yeast may be used with engineered glycosylation when appropriate.
- Enzymes: Secreted expression (yeast/mammalian) with co-factor supplementation and secretory pathway tuning to maximize active species.
- Cytokines (often small/basic and cysteine-rich): Secretion-forward designs with tuned redox environments; mammalian systems when glycosylation impacts receptor binding or half-life.
Q2: How do you control glycosylation and disulfide formation to preserve bioactivity?
We combine upstream control with orthogonal analytics:
- Redox tuning (glutathione ratios, DO/pH strategies) and chaperone management to favor native disulfide pairing.
- Media/feed and temperature shifts to modulate glycan processing; where needed, host selection or glyco-engineering to reach target sialylation and minimize high-mannose.
- Verification via intact and peptide-mapping MS, disulfide mapping, released/2-AB/FLR glycan profiling, and functional readouts (e.g., receptor binding kinetics by SPR/BLI, JAK/STAT pathway activation for cytokines).
Our products and services are for research use only.
