Biofortuna Limited
Biofortuna is a specialist contract development and manufacturing organisation providing Genomic services, custom development and manufacturing support. Operating from state-of-the art, humidity-controlled premises, and benefiting from ISO 17025 accreditation, ISO 13485 certification and FDA registration, we have a proven track record in the development and large-scale manufacture of PCR and LAMP molecular assays and Immunoassays.
Company details
Find locations served, office locations
- Business Type:
- Service provider
- Industry Type:
- Medical Monitoring
- Market Focus:
- Nationally (across the country)
About Us
For more than ten years, we have been forging partnerships with leading assay developers and earning a reputation as a trusted outsourcing partner for the provision of genomic services, custom development and contract manufacturing services.
Our services are varied, but whether we are supporting diagnostic developers, food technology experts or genomic specialists our guiding principles are the same; to form long term partnerships and become a valued extension of your team.
Operating from state-of-the art, humidity-controlled premises, and benefiting from ISO 13485 certification, ISO 17025 accreditation and FDA registration, we have a proven track record in the development and large-scale manufacture of PCR and LAMP molecular assays and Immunoassays.
Our service portfolio includes:
- Genomic Services
- Custom Development
- Lyophilisation (freeze-drying)
- Contract Manufacturing
- Dispensing and kitting
Our lyophilisation expertise enables PCR amplification assays and immunoassays to be transformed into soluble, freeze-dried cakes or beads, removing the need for cold chain storage.
Quality
Working with small and large blue chip companies we perform all work within a stringent quality management system.
We are ISO 13485 certified, ISO 17025 accredited and FDA CFR21 part 820 compliant company. We integrate our quality management system and design control standards within all our design, development and production projects.