cGMP MANUFACTURING

Drug Substance

Northway Biotechpharma is one of a few CDMOs able to offer cGMP drug substance manufacturing services based on both microbial fermentation technology and mammalian cell culture.

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

cGMP Manufacturing

Drug Product

From formulation development to sterile fill-finish, Northway Biotechpharma supports your product’s development through every step of the journey.

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cGMP MANUFACTURING

Cell Banking

We provide master and working cell bank manufacturing for both mammalian and microbial cell culture according to cGMP and ICH guidelines.

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