Andrew Bulpin, Head of Process Solutions Strategic, Marketing & Innovation, MilliporeSigma
A: Recent advancements in continuous chromatography and Single-Pass Tangential Flow Filtration (SPTFF) are all contributing to significant improvements across the complete process. Continuous chromatography increases productivity over traditional batch processes by cycling multiple columns through various sub-steps in parallel, allowing for constant capture and elution of protein. SPTFF has been demonstrated to de-bottleneck a variety of process steps and improve product quality, and is easy to implement with existing equipment. These important process innovations lead to improved efficiencies and process robustness, which in turn lead to significantly reduced operating and capital costs.
Michael Murray, Downstream Process Development, FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
A: The most significant development is the advance of continuous chromatography systems, which have the promise of reducing time, footprint and cost. Systems are currently in development, but issues such as control strategies and regulatory approaches still need to be determined.
Kimo Sanderson, VP Marketing and Client Services, Asahi Kasei Bioprocess America, Inc.
A: The aforementioned improvements in resin and virus filter capacities and new concentration techniques have all been significant. Inline buffer dilution has been particularly noticeable since buffers are used in effectively all downstream unit operations at high volumes. The ability to produce all of the necessary buffers accurately, on demand, from a small footprint buffer station, has significantly reduced the floor space and manpower required for modern downstream processing suites. Further, newer bioprocess chromatography systems are now incorporating IBD technology while also allowing the expected gradient formation — a two-in-one solution that promises to further streamline downstream processing.