A Next-Generation Sequencing company was looking for a partner to outsource the dispensing and kitting of their CE-marked kit.
Biofortuna were required to:
Transfer a dispensing procedure for a complex NGS kit to its manufacturing facility.
Complete an extensive validation plan that included; dispense volumes, plate seal, adverse transport and packaging studies.
Provide a stable partner with a robust manufacturing process for transferring pipeline products.
Offer options for the launch of version two of the kit currently in manufacture with further USP options and benefits for the end user.
The client is now routinely manufacturing with Biofortuna to satisfy increased demand of its CE-marked kits.
