IVD Contract Manufacturing
Avioq, a trusted clinical diagnostics company, has developed a broad line of diagnostics in-vitro assays for the clinical lab. With this experience, we can now offer extensive contract development and manufacturing services.
GMP Contract Manufacturing
Our manufacturing facility is FDA (BLA) licensed and ISO 13485:2016 certified. The facility includes a Bio Safety Level 2 facility for large scale virus production, a suite for recombinant protein production either in mammalian cells or bacterial cells, a multi-room suite for reagent manufacturing, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials.
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. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation.
The facility is fully equipped to perform the conjugation of purified antigens or monoclonal antibodies to a marker, e.g., horseradish peroxidase (HRP), alkaline phosphatase (AP), avidin or biotin. Methods for protein characterization include SDS-PAGE, Western Blot, scanning densitometry, protein concentration determination, and HPLC.
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.
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