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 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.

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.