April 30, 2020
How scale-up technologies for bulk drug substances will help the industryReading time: < 1 minutes
In the course of a webinar Thomas Wurm explained the importance of scale-up technologies for the biopharma industry. The entertaining presentation was among other interesting facts, demonstrations and studies also about the link to the current situation with COVID-19: as soon as one vaccine against the pandemic will be approved from FDA and EMA, how can manufacturer scale up from clinical phases to commercialization by maintaining the same product quality?
For drug substances/product/cells, freezing is an often-required step to ensure product stability and quality. For that step are either bottles or bags (both single-use) or stainless-steel vessels (multi-use) used. Single use options are preferred but bottles are open handling and limited in size and scalability. Single-use bags are closed systems but getting brittle and sensitive by low temperature (breakage is a risk) and furthermore there is no bag manufacturer independent freeze-thaw platform.
The single use technology platforms developed by Single Use Support offer scalable bag independent freeze and thaw platforms with same freezing/thawing kinetics over all phases.
Thomas Wurm gave insights into the approach of how Single Use Support provides biopharma industry with the most optimal scale-up technologies on the market. He also showcased the freezing with the RoSS.pFTU Labscale (for up to 5 l) and presented RoSS.pFTU Large Scale (for up to 200 l).
The recorded webinar from April 28 can be watched here: