Services, capacity and locations

Services

  • Synthesis development and process engineering
  • Analytical development and testing
  • Particle engineering
  • Scale-up
  • Validation
  • Production up to commercial scale
  • Regulatory support 

 

Capacity

  • Total volume of reactors 320 m3
  • Reactor sizes vary from 60 l to 6300 l
  • Annual API capacity over 400 metric tons
  • High-potency APIs (cytotoxic and non-cytotoxic) from grams to metric tons

 

Regulatory and compliance

  • DMF compilation, maintenance and consultancy
  • Experience in filing in e.g. the USA, Canada, EU DMF/CEP, Japan, Taiwan, China, Brazil, Australia
 

 

Services by Location

1. Espoo

  • R&D
  • Kilo facility
  • QA/QC
  • Regulatory Affairs
  • Administration

2. Oulu

  • Pilot plant
  • Specialised in the production of highly potent compounds – fully automated
  • Up to OEB class 5 (0,1-1 µg/m3)
  • QA/QC

3. Hanko

  • Large scale production
  • Fully automated API production
  • Up to OEB class 4 (1-10 µg/m3)
  • QA/QC