Manufacturing

Our FDA registered and ISO 13485 certified manufacturing facilities allow us to provide everything from small-scale pilot batch manufacture to full commercial production, with a range of automated liquid handlers, semi-automated plate sealers and bag sealers. We will carry out a full transfer to production process, with triple batch validation, to ensure your kits are made to the highest of standards.

 

 

We can provide a full range of manufacturing services, including:

  • Validation of mixes and IVD kits
  • Technology transfer from development to production
  • Manufacture of both molecular diagnostic and immunoassay kits
  • Regulatory assistance and submissions

Our state of the art facilities are both temperature and humidity controlled (down to 5%).

Contact Biofortuna for more details and a no-obligation quote.