A leading US-based clinical testing authority specialising in human medical and veterinary diagnostic testing of fungal infections approached Abingdon Health to optimise, transfer and scale up the development of two new lateral flow tests (LFTs) in their suite of IVD test devices, over the course of a complex, multi-year project to deliver ready for market products.
Following completion of the Feasibility phase of project #1 with another provider in 2023 and a competitive tender exercise, the client awarded Abingdon the contract for Optimisation and Scale Up services for product #1. A rigorous, project setup process was completed, including full Proof of Concept (POC) documentation reviews in alignment with Abingdon’s QMS and New Product Development procedures. A second project was commissioned by the client, following the success of the first.
Challenges
During the technical transfer and scale up phases for product #1, Abingdon’s team uncovered issues with the stability of the gold conjugate, meaning that the conjugate would not withstand the typical manufacturing process necessary to produce the required volumes of the device routinely.
In project #2, the Abingdon team identified issues during the pilot phase of Scale Up around non-specific binding, resulting in false positives in the prototype test.
Solution
Project #1
Abingdon's Contract Development Services team collaborated closely with the client, applying their extensive expertise and specialised CDMO experience to ensure consistent project updates and communication.
The team was able to pivot the conjugation process to an alternative significantly improved process addressing the previous issues the customer had seen. This was combined with the manufacturing team’s willingness to adjust their schedules to allow for an expedited pre-build process that would reduce the minimum required stability time. By refining processes, Abingdon’s team was able to deliver the pre-build process work quicker, to allow for the shorter stability lifespan of the conjugate in pilot and future batches.
Project #2
Proof of Concept for this project moved efficiently. The extensive testing conducted prior to pilot, allowed the Abingdon team to determine that the non-specific binding challenge (leading to false positives) was a result of the drying process affecting larger batches, not present within the small-scale R&D Proof of Concept and Optimisation phases.
Results & Impact
Project #1
The lateral flow test was validated in-house by Abingdon and is currently undergoing clinical trials. The client’s team expects these results shortly and to submit to the FDA for 510(k) approval later this year. The next step is to move the product into routine manufacturing batches, a process made much simpler due to the robust technical transfer process already undertaken.
Project #2
Given the innovative nature of this new diagnostic product development work, the client agreed to additional work packages to determine the extent of the non-specific binding and attempt to eradicate the issue through a series of experiments. This led to the building of a new pilot batch which exceeded expectations in terms of performance. Device validation batches were immediately authorised following the testing of the pilot lot and we have successfully moved through into the technical transfer process.
Why Did You Choose Abingdon Health?
“The first project awarded to Abingdon Health was started based on online reviews and testimonials. The second project was authorized based on the professionalism and scientific knowledge demonstrated with the first project. The teams have been easy to work with, providing constant updates and engaging in a healthy scientific discussion. My team is looking forward to wrapping up the second project and launching a third.”
