LUINA has a well-established process development teams with extensive 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.
LuinaBio holds licenses through TGA, APVMA, OGTR and DAF for manufacturing and storage of both clinical stage and commercial API products, and finished pharmaceutical goods. Our facility can import API and finished products for clinical trials and store them in quarantine prior to local ethics approvals, which enables faster trial start-up.
Our fermentation scale ranges from 5L to 500L. We also have fed batch capabilities and cell recovery, to include discrete centrifugation, continuous centrifugation and ultrafiltration. Additionally our microfluidics high pressure homogenizer is suitable for cell rupture.
We can 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.
In addition to manufacturing API, we can provide secondary packaging, warehousing and distribution of clinical trial batches for use in Australia and New Zealand.