Regardless of all potential pitfalls from the current pandemic Single Use Support has reached the next milestone in its thriving development: The large scale freeze/thaw platform has been commissioned on site in California/US virtually. A major CMO (contract manufacturing organization) in the Bay Area, producing biologics, small molecules, bioconjugates and cell and gene therapies, will be frozen and thawed by the technology from the Austrian biotech supplier.
The site acceptance test (SAT) of the mechatronic installation represents the commissioning of the system as is usually held on site of the customer. Considering the lockdown and travel restrictions causing by the COVID-19 outbreak in Europe and the USA, we were forced to search for alternate solutions to perform the last test until the platform will be deployed for the freezing and thawing of monoclonal antibodies (mAbs). The resulting virtual commissioning of the Freeze and Thaw platform was a SAT in a very unusual manner. Thanks to the adjustability of the setting at the customer’s site, we could deliver required materials upfront and webcast the SAT until all tests have been successfully completed.
The CMO was successful in loading a recipe and in running several freeze and thaw cycles. Also, a complete training session has been conducted virtually, which as well was considered very useful.
The RoSS.pFTU Large Scale from Single Use Support is a plate-based freeze and thaw platform for up to 200 liters of drug substance per run. Out of many orders from various customers around the globe the popular large scale installation is the first of this kind at the westcoast/US that has been officially commissioned. Many more will be to follow soon, as serial production is in full swing.
Single Use Support has developed different scalable RoSS.pFTU platforms that are designed for RoSS shells.