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 dispensers, semi-automated plate sealers and bag sealers. We will carry out a full transfer to production process, with triple batch validation, to ensure your products are made to the highest of standards.
We can provide a full range of manufacturing services, including:
- Manufacture of both molecular diagnostic and immunoassay kits
- Technology transfer from development to production
- Coating, blocking and drying of microtiter plates
- Freeze dry and stabilisation of molecular diagnostics reagents using our state of the art temperature and humidity controlled (down to 5%) clean room facilities
- Triple batch manufacture and creation of manufacturing records to ISO 13485 compliance
- Development of detailed QC procedures
- Full validation of final IVD kits
- Regulatory assistance for CE and FDA submissions
Contact Biofortuna for a discussion on our capabilities.