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.
- Cell culture optimization for high yields and low cost
- Antibody and antigen production from engineered cell lines
- 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
Cell Line Capabilities
- Cell line growth performance evaluation
- Cell line yield, stability and protein expression characterization
- Full-time 24/7 monitored cryostorage
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.
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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