LUINA has a well-established process development teams with excessive experience in microbial upstream and downstream development for all type of biopharmaceuticals (incl. BSL-2 pathogens). The different teams are ready to collaborate with you on the development of your biopharmaceutical. Our philosophy is “Trust us to make it right”. This means that we always focus on your long term goals and plan with these in mind. So when we develop a process that will work at the scale of production required for Phase I clinical trials we already keep the eventual commercial scale in mind, and scale-down the process to fit your early phase clinical requirements in the shortest possible time. This approach has been repeated successfully time and time again, resulting in multiple products that are now licensed biopharmaceuticals.
Approval and Post-Approval