
LYOFLOW: A New Freeze-Drying Processes Development Paradigm
Jaume Vallet CEO, Pere Tapiolas Innovation Manager, Toni Sanz Automation Software Development at COMSER Pharma. Introduction In 2007 the ICH (International Conference of Harmonisation) guide Q8 defined the drug production processes development based on the introduction of quality in the process (Quality by Design). Since that, the industry has made an innovation effort to introduce…