We provide flexible mammalian (CHO/HEK) drug substance development and manufacturing — from early process development through clinical and commercial production — using a combination of single-use and stainless-steel bioreactors up to 2000 L
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.
~2000 m² facility with two independent, segregated production streams.
Flexible bioreactor train covering development to commercial scales (50 L–2000 L).
Integrated purification train including depth filtration, chromatography and UF/DF.
21 CFR Part 11-compliant systems and robust data integrity frameworks.
GMP Master & Working Cell Banks; sterile expansion through seed-rack to bioreactor
Fed-batch or perfusion in single-use/stainless systems (50 L–2000 L)
Depth filtration (~9.6 m² holders) for cell removal
Multi-mode columns (up to 1200 mL/min capacity), TFF concentration & buffer exchange (0.5–5 m²)
Pre-/post-viral segregation, process validation, and QC sampling
Current & Future Capacity:
Our dual-stream architecture and scalable single-use capacity allow us to support multiple client programs in parallel.
Clinical and commercial batches
Complete validation documentation
Full analytical testing results
Process records, batch records, QC reports
Complete microbial drug substance manufacturing solutions
Small-scale microbial manufacturing for development and early clinical phases
Complete drug product services including aseptic fill and finish
Explore our comprehensive biologics development and manufacturing platform
