Drug Substance Manufacturing
Your end-to-end partner for the development and manufacturing of complex fermentation-based APIs.
We combine strain engineering, AI-driven process development and advanced downstream purification to scale from vial to 5 kL, delivering higher titers, robust processes and reliable cGMP supply.
From strain to commercial supply
01
Strain Engineering
- Genetic and metabolic engineering
- High-throughput mutant screening
- Specialization in microbial cultures
- Engineered strains with up to 5× titer increase over wild type
02
Process Development and Optimization
- DoE and AI/ML-based process modeling and cost optimization
- CPP and CQA mapping
- From shake flask to 50 L pilot
- End-to-end process developed with 3× yield increase
03
Process Scale-Up and Commercialization
- Advanced modular manufacturing platforms
- Upstream capabilities: from vial to 5 kL fermentation
- Aqueous and organic-phase downstream processing
- OEB 4/5 (HPAPI) handling
04
Analytical Method Development and Validation
- Assay determination and impurity profiling
- Stress and stability studies
- Structural and material characterization
- Method development and validation for in-process testing
From vial to 5 kL
Process scale-up and commercialization will be undertaken at our upcoming cGMP-compliant manufacturing facility in Raebareli, India.
Facility Highlights
Fermentation
- Fermenters
- 50 L, 500 L and 5 kL
- Media preparation
- 3 kL, with nutrient, base, acid and antifoam dosing
- Inoculum preparation
- Dedicated HVAC, Grade C
- Feeding
- Multi-feed processes
Downstream Recovery & Purification
- Whole-broth extraction
- 10 kL reactors
- Centrifugation
- Continuous and decanter
- Ion-exchange chromatography
- Up to 1,200 L
- Low-pressure chromatography
- Up to 200 L
- RP-HPLC polishing
- 450 mm ID column
- Membrane filtration
- Ultra-, micro- and nanofiltration
Powder Processing
- Drying
- VTD and ANFD, with isolator containment
- Micronization
- Isolator containment
- Crystallization
- Nutsche filtration with flexi-isolator containment
- Environment
- Dedicated HVAC, Grade D area