Cell Culture Development
Avioq has the experience, specialized facilities and mature Quality System to take your engineered mammalian and bacterial cell lines from the initial development phase to a high-throughput cGMP manufacturing process.
We optimize the production conditions for your cell line to ensure consistently high yields at the lowest production cost, and our design control procedures are capable of fully documenting the development process to support submission to Regulatory agencies.
Biomanufacturing Services
Cell Culture Optimization
Antibody and Antigen Production
Protein Purification, Analysis and Characterization
Antibody and Antigen Production
Protein Purification, Analysis and Characterization
Cell Line Capabilities
Cell line growth performance evaluation
Cell line yield, stability & protein expression characterization
Full-time 24/7 monitored cryostorage
Cell line yield, stability & protein expression characterization
Full-time 24/7 monitored cryostorage
Quality Systems
FDA 21 CFR Part 820
ISO 13485:2016
Quality Audits
ISO 13485:2016
Quality Audits
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.
Scalable purification processes based on standard or custom bioprocessing techniques available to enable large scale generation of biochemicals suitable for further development and/or licensing.
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.