White Paper: Automated, Single-Use Purification Platforms In Biopharmaceutical Production

By Karl G. Schick, Ph.D., VP of R&D, SciLog Inc.

The use of disposable bioreactors and single-use purification platforms for Normal Flow Filtration (NFF), Tangetial Flow Filtration(TFF) and Preparative Chromatography have received significant attention in years. Up to very recently, the use of single-use purification platforms was limited almost exclusively to manually operated systems. The transitioning from manual to automated single-use purification systems has been limited primarily by the availability of appropriate sensors and detectors and other in-line system components. The need for gamma-stable, pre-calibrated sensors and pre-sterilized, pre-validated system components has given rise to new and innovative tecnologies.

Manually operated, single-use purification platforms have been entusiastically embraced by the biopharmaceutical industry. However, fully automated, single-use purification platforms have, until recently, not been commercially available. In addition to reliable single-use platform compnents, the availability of automated, sensor-based liquid handling capability are a critical pre-requisute for platform automation. automated data acquisition, documentation and communication are also critically important in automation, single-use purification platforms. This last requirement is aided by platform OPC connectivity capable of real-time data transfer to a dedicated data historian. The use of historical data for model predicted control (MPC) greatly enhances process knowledge and can provide significant economic benefits.