Facilities, laboratories and
Batch manufacture of a bespoke paediatric variant of the FOX® nebuliser comprised multiple stages, requiring an in-depth understanding of the device platform and its engineering systems.
We have the expertise to develop manufacturing processes ranging in scale from laboratory testing all the way through to commercially relevant scale-up, including the manufacture of clinical supplies for large-scale clinical studies. This enables us to offer a seamless transfer out to commercial manufacturing sites.
Recently, a cross-functional team of almost 50 colleagues manufactured and delivered nearly 6,000 devices of a bespoke variant of the FOX® nebuliser with face-mask and oxygen feed for use in a Phase IIb paediatric study. Batch manufacture comprised multiple stages, requiring an in-depth understanding of the device platform and its engineering systems, encompassing mechanical, software and electronic elements.
Control checks for aerosol performance and end-of-line quality control release testing were performed, with all devices CE marked and labelled with full serial numbering traceability, before being hygienically packaged. Results of the clinical trial were positive for the primary endpoint of anti-viral efficacy and target exposure was achieved.