Coalesce has built its first clinical batch of dry powder inhalers in its ISO Class 7 cleanroom.
The ability to supply devices for clinical trials is a fundamental element of our Concept to Clinic® process. This level of vertical integration is rare amongst contract design organisations, and our clients benefit enormously from knowing that the devices supplied to their clinical trials are built to stringent specifications by knowledgeable engineers under a robust, ISO 13485-certified quality system (a surveillance audit, by BSI, our notified body. in March 2017 was passed with no nonconformities).
Coalesce has developed a simple, cost-effective, and robust supply-chain for building batches of devices for early clinical studies. Components are moulded under GMP cleanroom conditions by a Coalesce-approved CMO. We have developed internal processes for stock management, IQC, in-process checks, and release testing. All of the processes have been designed to ensure that the batch of devices that is released to clinic meets the Device Functionality Profile (DfP).
For this batch of devices, IQC tests included visual inspection and metrology using Coalese’s Keyence VHX-5000 digital microscope. In-process checks and release-testing involved extensive airflow characterisation on our bespoke ACTR2 digitally-controlled airflow-characterisation test-rig, as well as independent analysis conducted by a third-party Contract Research Organisation (CRO).
This batch of devices is destined for a Pharmacokinetic (PK) bioequivalence study, which will be carried in the EU within the coming months.