Drug Substance Capacities
Innovative process engineering to customize biopharmaceutical manufacturing.
As a world class CDMO facility, we offer small, pilot and large-scale drug substance capacities for clinical and commercial use across mammalian, microbial and viral vector platforms with flexibility to adopt to various other modalities such as cell and gene therapy, etc. We have demonstrated ability to build world-class facilities compliant with global regulatory standards with industry leading timelines. Our development and manufacturing teams are highly experienced in tech transfer, scale-up and validation of biopharmaceutical drug substance processes.
Mammalian
4L and 20L
Upstream and downstream for process development
50L and 200L
Upstream and downstream for process scale-up
50L → 200L/500L → 2000L
2 X 2000L
Microbial
5L and 20L
Upstream and downstream for process development
50L
Upstream and Downstream for process scale-up
1 X 1000L
50L → 300L → 1000L
Upstream train for process validation and commercialization
Mammalian
4L and 20L
USP and DSP for process development
50L and 200L
USP and DSP for process scale-up
4 X 2000L
Single-use trains (Q2-2022) for process validation and commercialization
50L→200L/500L→2000L
Upstream train for process validation and commercialization
Microbial
5L and 20L
USP and DSP for process development
50L
USP and DSP for process scale-up
1 X 1000L
Stainless steel fermenter train for process validation and commercialization
50L→300L→1000L
Upstream train for process validation and commercialization
Viral Vector
4L, 20L and 100L
USP and DSP for process development
50L and 200L
USP and DSP for process scale-up
20 X 2000L
Single-use trains for process validation and commercialization
50L→200L→2000L
Upstream train for process validation and commercialization
Mammalian
Process Development
- USP and DSP: 4L and 20L
Process Scale-up
- USP and DSP: 50L and 200L
Process Validation & Commercialization
- 4 X 2000L single-use trains (Q2-2022)
- Upstream Train: 50L→200L/500L→2000L
Microbial
Process Development
- USP and DSP: 5L and 20L
Process Scale-up
- USP and DSP: 50L
Process Validation & Commercialization
- 1 X 1000L stainless steel fermenter train
- Upstream Train: 50L→300L→1000L
Viral Vector
Process Development
- USP and DSP: 4L, 20L and 100L
Process Scale-up
- USP and DSP: 50L and 200L
Process Validation & Commercialization
- 20 X 2000L single-use trains
- Upstream Train: 50L→200L→2000L