Drug Substance

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

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• cGMP manufacturing at final production scale