Capabilities
Full-lifecycle biologics services
We support programs across the complete development lifecycle — from sequence through IND-ready technical package.
Cell Line Development
Cell Line Development
Stable CHO/HEK cell lines engineered for multi-g/L productivity and manufacturability.
- ✓ Transient and stable transfection in CHO and HEK293
- ✓ High-throughput clone screening with quality assessment
- ✓ Clonal selection with monoclonality documentation
- ✓ Stability studies and cell banking (RCB / WCB)
Upstream & Downstream Process
Upstream & Downstream Process
Scalable fed-batch processes, purification strategies, and robustness studies for GMP readiness.
- ✓ Bioreactor development (bench to pilot scale)
- ✓ Fed-batch and perfusion process design
- ✓ Purification platform development (Protein A, IEX, HIC)
- ✓ Process robustness and scale-down model validation
Analytical Development
Analytical Development
Fit-for-purpose analytical methods and characterization to support IND-ready dossiers.
- ✓ Identity, purity, potency, and safety testing
- ✓ Extended characterization (glycans, charge variants)
- ✓ Comparability and forced-degradation studies
- ✓ Method qualification packages for regulatory submission
Regulatory Documentation
Regulatory Documentation
CMC sections and appendices to streamline IND/IMPD submissions. Risk-based qualification approach.
- ✓ IND CMC module (3.2.S sections)
- ✓ Development history reports (DHR)
- ✓ Risk assessments and comparability protocols
- ✓ Pre-IND meeting briefing document support
Expert Consulting
Expert Consulting
CMC strategy, CDMO selection, DoE training, and fractional R&D leadership for biotech programs at critical inflection points.
- ✓ CMC strategy & CDMO selection
- ✓ DoE/JMP training & process consulting
- ✓ Scientific Advisory Board (SAB) roles
- ✓ Fractional CMC leadership & IND support
Ready to discuss your program?
Tell us about your molecule, timeline, and goals. We'll propose a tailored development path.