Drug Substance Capacities

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

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

Single-use trains (Q2-2022) for process validation
and commercialization

4 X 2000L

Upstream train for process validation and commercialization

Microbial

Microbial

5L and 20L

Upstream and downstream for process development

50L

Upstream and Downstream 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

Other Modalities

Other Modalities

4L, 20L and 100L

Upstream and Downstream for process development

50L and 200L

Upstream and Downstream 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

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