Learn more about our large scale manufacturing services and capabilities.
CHO/HEK cell line development and optimization for high productivity and robust performance.
Fed-batch and perfusion processes across multiple scales with 24/7 process monitoring and control.
Multistep chromatography, filtration and UF/DF delivering high-purity drug substance.
Aseptic fill-finish support through partners and/or internal drug product capabilities.
Transition from pilot → commercial maintaining key parameters (mixing, shear, oxygen transfer).
Stainless steel at 500 L to 230,000 L scale; multiple trains for campaign flexibility.
High-capacity chromatography skids, virus clearance steps (for mammalian), large-scale UF/DF systems (>10 m²).
Stage-wise process validation (PPQ), cleaning validation, environmental monitoring, lifecycle approach per FDA & EMA guidelines.
Commercial packaging, serialization, regulatory labeling, controlled cold chain distribution globally.
Complete PPQ documentation and lifecycle validation data
Commercial manufacturing documentation with full traceability
CoAs with comprehensive quality testing for commercial release
Real-time and accelerated stability studies supporting shelf life
Complete support for BLA/NDA/MAA submissions and updates
Development-scale microbial manufacturing for early-phase programs
End-to-end microbial fermentation and purification services
Aseptic processing and packaging for your drug product needs
Discover our integrated biologics development platform
