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Drug Substance

Northway Biotech 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.

In our sites in Europe and the US, 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.

Drug Substance Manufacturing Capabilities

  • Cell culture manufacturing 
    • 50 L single-use wave bioreactor
    • Four separate mammalian production lines in the Vilnius site:
      1. 10 L
      2. 10 / 200 / 1000 L single-use bioreactors
      3. 10 / 50 / 500 L / 2000 L single-use bioreactors
      4. 10 / 50 / 500 / 2 x 2000 (4000) L single-use bioreactors
    • One mammalian production line in the Boston site
      1. 10 / 50 / 500 / 2000 L single-use bioreactors
    • TFF system up to 15 square meters
  • Microbial manufacturing 
    • Three separate microbial production lines in the Vilnius site:
      • 10 L
      • 30 / 300 L working volume stainless steel fermenter line
      • 30 / 300 / 3000 L working volume stainless steel fermenter line
    • One microbial production line in the Boston site:
      1. 30 / 300 L working volume stainless steel fermenter line
  • Pilot batches and scale-up
  • cGMP manufacturing at final production scale

cGMP Manufacturing

Drug Product

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

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Cell Banking

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

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