Lyophilisation of LAMP-based Diagnostic Kit

A diagnostics company looking for a contract services provider have used Biofortuna to launch their first CE marked, lyophilised LAMP based kit onto the market. This kit will be used for the direct detection of meningococcus and significantly reduces set up times from current preferred methodologies.

The client was specifically looking for a contract provider to:

  • Develop a lyophilisation process for a custom mix and plastics that would result in long-term ambient temperature stability without compromising performance.
  • Perform a technology transfer of feasibility work to full scale manufacture.
  • Validate all aspects of the manufacturing process in line with ISO:13485 requirements.
  • Provide a stable manufacturing partner with a robust process for transferring pipeline assays.

The client now has several further assays due for launch via Biofortuna.