Lyophilisation of Point of Care (POC) IVD qPCR assay and controls

Biofortuna are currently manufacturing assays and controls for a UK based molecular diagnostics company, producing a POC IVD device for the diagnosis of infectious diseases.

Biofortuna were required to:

Develop a custom lyophilisation process for a qPCR based assay for the detection of infectious diseases.
Develop a custom lyophilisation process for multiple control samples.
Perform a comprehensive technology transfer of feasibility studies to full scale manufacture to support product launch.
Validate all aspects of the manufacturing process to ISO13485.
Provided a stable manufacturing partner with a robust process for transferring a pipeline of assays

The client is now actively seeking device placements and are transferring multiple infectious disease assays for production with Biofortuna.