Prolight’s COO: “The pilot line sets the stage for scalability”
Prolight Diagnostics recently completed a business review of the pilot manufacturing line at its partner, FlexMedical Solutions. The production line will supply cartridges for the upcoming clinical performance study of the Psyros POC platform and facilitate a seamless transition to full-scale commercial production. Prolight’s COO, Karl Bullen, shared insights into the progress and next steps.
Psyros is Prolight Diagnostics’ digital point-of-care platform designed to detect low levels of troponin in the blood, providing a fast and reliable diagnostic tool for myocardial infarction. The system consists of a portable analyzer and a single-use cartridge. Only a small drop of blood is required to perform the test.
Partnership with FlexMedical Solutions
In March, Prolight entered into a contract manufacturing agreement with FlexMedical Solutions (FMS) for the production of the disposable cartridge in the Psyros system. FlexMedical has extensive experience in IVD cartridge manufacturing processes and expertise in fully validating facilities.
In Q2, Prolight completed the final design of the cartridge intended for commercial use. FMS have since made great progress on the construction of the pilot manufacturing process line to facilitate regulatory approvals, including the clinical performance study and the production volumes required for commercial launch.
Business review shows progress
Prolight Diagnostics recently conducted a review of FMS’s progress, which included a thorough inspection of the pilot cartridge manufacturing line and its supporting facilities.
– It was exciting to see the significant progress FMS has made over the last few months. With building works now complete, it was great to see the first wave of production equipment being installed, said COO Karl Bullen.
Simple design enables streamlined production at competitive costs
The manufacturing processes and cartridge are designed to enable large-scale production, with high levels of automation and low production costs. The cartridge consists of only a few components, each carefully selected for efficient and streamlined production. This approach not only enables outsourcing of the manufacturing, but also allows for highly competitive costs.
COO comments
BioStock contacted Prolight Diagnostics’ COO, Karl Bullen, to learn more about the progress in the collaboration with FMS.
Can you share more details on the progress FMS has made in recent months, and the key findings from your recent business review?
– FMS has completed the building works for the pilot line and the co-located laboratory. This is a significant step, as the completion of this phase now allows for the installation of equipment to begin.
– One key finding from the business review highlighted that FMS are well organised with good project governance processes giving Prolight high levels of confidence that they will continue to deliver. During the business review, FMS also demonstrated a number of innovative solutions they have put in place to optimise the build process and minimise cost.
What are the upcoming steps in setting up the cartridge manufacturing process?
– The most significant upcoming steps will be the delivery of bespoke manufacturing equipment, which is currently being built by specialised equipment supplier.
With a clinical performance study on the horizon, how is Prolight Diagnostics preparing for this upcoming step, and how will the pilot line support those efforts?
– Prolight is currently fully focused on completing pre-clinical studies to derisk the formal clinical performance study planned for 2025. Cartridges produced by the pilot line will be used for the clinical performance study.
How do you envision the partnership with FMS evolving as Prolight moves towards full-scale production and market launch?
– Once the pilot line is established, we will continue to work with FMS to optimize the production process whilst in parallel work towards development of the high-volume commercial line required for the years following launch.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
