Our flexible capacity and equipment trains, combined with our agile, collaborative approach, gives us the ability to scale up your product – from pilot batch to clinical and commercial quantities – to accelerate your time to market.
We offer single-use equipment, and all microbial and mammalian activities are conducted on completely separate manufacturing lines. Our manufacturing facilities are cGMP-compliant and meet all FDA and EMA requirements for biopharmaceutical production.
Furthermore, Northway Biotechpharma is expanding our microbial fermentation capacity by adding a completely new production facility with a scale up to 3,000 L working volume.
Drug Substance Manufacturing Capabilities
- Cell culture manufacturing
- 30 L single-use wave
- Three separate mammalian production lines
- 10 L
- 10 L / 200 L / 1000 L single-use bioreactors
- 10 L / 50 L / 500 L / 2000 L single-use bioreactors
- TFF system up to 15 square meters
- Microbial Manufacturing
- 10 L
- 30 L working volume fermenter
- 300 L working volume fermenter
- Continuous-flow centrifuge
- Pilot batches and scale-up
- cGMP manufacturing at final production scale
- Facility expansion at a glance
- 5 stories building
- 12000 L refolding capacity
- 3000L working volume microbial origin processes with appropriate downstream
- Highly flexible and cost efficient hybrid facility: combination of stainless steel and single use equipment
- Wide range process application: soluble protein and inclusion bodies