IVD Contract Manufacturing
Avioq, a trusted clinical diagnostics company, has developed a broad line of in-vitro diagnostic assays for the clinical lab. With this experience, we offer extensive contract development and manufacturing services.
cGMP Contract Manufacturing
Our manufacturing facility is a FDA licensed facility for both BLA and PMA products as well as an ISO 13485:2016 certified facility. The services include:
- IVD and RUO Contract Manufacturing
- Product Kitting Services
- Bio Safety Level 2 Facility for Large Scale Virus Production
- Multi-room Suite for Reagent Manufacturing
- Formulation of Bulk Reagents
- Medical Device Prototypes and Product Testing
- Lyophilization Services
- Custom Media Fill Solution
Kit Assembly Services
Kitting Finished Product
Pouch Sealing
Custom Packaging
Regulated Kit Labeling
Pouch Sealing
Custom Packaging
Regulated Kit Labeling
Finished Device Assembly
Hand Assembly
Sourcing of Components
Lot Product Management
Quality Control
Sourcing of Components
Lot Product Management
Quality Control
Shipping Services
Domestic and International
Pallet Shipments
Warehousing
Temperature Monitoring
Pallet Shipments
Warehousing
Temperature Monitoring
Bio-manufacturing Capabilities
Bio-manufacturing and analytical capabilities include recombinant protein production either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures.
Quality Systems
Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. Avioq has met all FDA 21 CFR Part 820 and ISO 13485:2016 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training. Avioq has proven processes with the successful commercialization of our own portfolio of in-vitro diagnostics kits.
Avioq applies our scientific, manufacturing and quality expertise to provide start-up companies or research institutions with immediate services and capabilities to take your assay/test to the next level of use and/or commercialization.