Contract Development and Manufacturing
Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, 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 production of antigens produced 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.
Our R&D facility is fully-equipped with modern laboratory spaces. The general laboratory space is divided into dedicated spaces for work in molecular biology, immunology and immunochemistry, microbiology, cell culture, and manufacturing process development. It also has a separate microbiology laboratory designed for work requiring BSL-2 containment conditions. Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD.
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. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.