Avioq is an in vitro diagnostic medical device manufacturer and a contract development, contract manufacturing organization.
Based in Research Triangle Park, North Carolina Avioq has a FDA licensed manufacturing facility and large, modern R&D laboratories.
Our products include an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor and cadaveric samples, which also has CE marking and Health Canada approval.
The Avioq HIV-1 assay is the only product with FDA approved claims for testing serum, plasma, dried blood spots, and oral fluid specimens.
The FDA approved HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.
The CE Mark version can also be used in epidemiological studies to distinguish recent from longstanding HIV-1 infection for incidence estimation.
Why work with Avioq for your next CDMO project?
Instead of using consultants who talk about the regulatory process we actually live it. We develop and manufacture our own FDA and CE Mark products to the highest standards.
The manufacturing facility is FDA (BLA) licensed and ISO 13485:2106 certified. The facility has been inspected numerous times by FDA and ISO, as well as by external partners.
Need a quick answer? We can help you with:
- Exploratory research
- Proof of concept projects
- Feasibility studies
- Research lots
If you entrust your project to Avioq, we will focus on getting your product through our mature Quality System, approvable by Regulatory Authorities, manufactured and to market as quickly as possible. Our team will guide you past the regulatory delays and pitfalls.
Custom Assay Development
Avioq’s research scientists are experts in ELISA assay development.
Working side by side Avioq provides efficiencies with shorter timelines to accelerate IVD product development and commercialization.
Our project team can move quickly to get your prototype assay ready without incurring large startup costs.
Cell Culture Development
We can take your engineered mammalian and bacterial cell lines from the initial development phase to a high-throughput cGMP manufacturing process.
BioManufacturing Services that we can offer you:
- Cell culture optimization for high yields and low cost
- Engineered protein purification, analysis and characterization
- Production scales from t-flasks to bioreactors
- cGMP production facilities and a fully developed Quality System
- cGMP Bio Safety Level 2 facility available
New Product Expertise
Our R&D, quality and manufacturing teams have successfully designed and developed numerous medical diagnostic products during the past 25 years.
Put that experience to work to get your product to the marketplace as quickly as possible.
Call Mike Cronin at 919.314.5535 or email us for a free consultation at [email protected].