Duplication or effortless Transfer of DSP-processes made simple with Pre-Packed SUPR columns. High Performance-Radial Flow Chromatography (HP-RFC) production columns for biopharmaceutical production currently range from a bed volume of ~5 liter up to 600 liter and Proxcys will be able to provide, pre-packed, ISO class 7 clean-room packed SUPR copies for all of them.
Process development can start at column volumes of 2ml. The SUPR radial columns support the transfer since pre-packed SUPR columns are identical copies of the parent process.
Product Registration and validation will remain valid. Therefore SUPR design specifications, process parameters and even material of construction (MOC) are kept identical too. The SUPR design is highly sustainable since parts can be reused or recycled compliant to the Closed loop supply chain goalsetting. Proxcys offers a replacement scheme to collect, process and replace spent columns.
When scaling up of traditional (axial) process becomes limiting, transfer to HP-RFC prepacked format can be an option and is quite simple, although process-validation of the transfer will be required.
More information?
A dedicated project team has been assigned to support the design, manufacturing, packing, validation and distribution of SUPR columns, to be contacted via SUPR-solutions@proxcys.com or telephone +31 591 677 447