Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | SEPTEMBER 15, 2017 | ➜ Angelo DePalma, Ph.D. Continuous processing has been a mainstay in process industries for de- cades, but is conspicuously rare in the manufacture of biopharmaceuticals. Back in 2000, Andrzej I. Stankie- wicz, Ph.D., of Delft University in the Netherlands made the case in Chemi- cal Engineering Progress for continu- ous bioprocessing as an extension of process intensification. More recently, Michael Phillips, Ph.D., director of next-generation process R&D at Mil- liporeSigma, assigned continuous processing to the highest (i.e., most sophisticated) level of process intensifi- cation, but also noted that "regulatory and technical issues are slowing down adoption." Continuous processing is progress- ing slowly, cautiously, in a way that is reminiscent of single-use bioprocessing 15 years ago. "We're seeing a greater appreciation for continuity, and many are starting by implementing islands of continuous processing within the larg- er batch bioprocess," notes Loe Cam- eron, director of analytics and controls at Pall. Biomanufacturers are inves- tigating continuous unit operations (both upstream and downstream), connecting two consecutive operations (e.g., cell culture and clarification), or combining downstream steps. "This entry level of continuous processing has been critical for manu- facturers to understand these processes more completely from the perspective of automation, orchestrating the con- nection between unit ops and the over- all process dynamics," Cameron says. Batch and fed-batch process devel- opers use micro-, mini-, and mid-sized versions of large processes to gain understanding of how manufacturing at scale might work. But, because full scalability does not exist for continu- ous or perfusion cell culture, processes that eventually employ perfusion culture begin life as batch cultures. "At some point during process devel- opment, while you're using fed-batch, you have to evaluate whether perfu- sion culture is appropriate," Cameron says. "If the intention is to go continu- ous, then the process development plan will be shaped toward that goal. But you wouldn't be running continu- ous at the smallest scale." Dual-Mode Purification Bind/elute chromatography is dif- ficult in continuous mode due to the discrete loading, washing, elution, and regeneration steps. With multiple columns, one column can be at one point in the process while another is doing something else. But multiple- column systems are complex to install and control—which is why Andrew Bulpin, head of process solutions at MilliporeSigma, believes that flow- through chromatography is a more appropriate entry point for continuous purification. Depth filters—a flow-through step based on diatomaceous earth or acti- vated carbon—are underappreciated for their size-exclusion and absorptive capabilities. In addition, flow-through Continuous Bioprocessing Is Coming CO N T I N U O U S B I O P R O C E S S I N G Vendors Bank on the Prospect of Successful End-to-End Continuous Manufacturing for Biologics Continuous capture processes may be carried out at GMP scale with LEWA's EcoPrime Twin, which is built on ChromaCon's Contichrom® CUBE technology.

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