Contract Manufacturing
Manufacturing at APIS
Our ISO 13485:2016 certified, bespoke manufacturing facilities at APIS Manchester allow us to provide prototype, pilot lots and commercial batches throughout phases of development and commercialization for both molecular diagnostic and immunoassay kits.
Quality
Our Quality Management System in operation at APIS Assay Technologies is compliant with ISO 13485:2016
Expertise
We have full design transfer capabilities and can perform full transfer to production processes incorporating prototyping and pilot kit manufacture. We can provide:
Design Transfer and Process Validation Capabilities
Prototyping – Early phase kit configurations
Pilot/Commercial Manufacture
Process Validation
Raw Material Sourcing
Commercial Scale Manufacture of both molecular diagnostic and immunoassay kits
Kit assembly and packaging
On site monitored cold storage capability
Development of detailed QC procedures
Full validation of final IVD kits
Regulatory assistance for CE and FDA submissions