This week at BPI in Boston, Pall Corporation launched the Cadence BioSMB Process system which it told us is the only continuous chromatography system on the market with the ability to scale from process development to GMP commercial production featuring a single use flow path.
The platform, which can operate with up to eight chromatography columns, offers biomanufacturers process-scale purification using feedstreams derived from fed batch bioreactors and is the latest offering in the firm’s continuous bioprocessing tech portfolio.
“The strong adoption of single-use technologies has been an enabler in the transition towards continuous bioprocessing; it offers the next logical step,” Pall’s senior marketing director of downstream processing Peter Levison told Biopharma-Reporter.
“Process intensification has made it possible for bioreactor volumes to decrease, making a 2,000L bioreactor feasible for mAb production. This process volume is the sweet spot for single-use technologies, as well as for continuous technologies,” he continued.
“In continuous processes the value proposition is higher quality and productivity in a smaller footprint, with shorter production times in comparison to a traditional batch process for the same product quantity.”
Combined with single-use tech, continuous processing falls into industry’s desire to be more flexible, allowing minimal molecule downtime, he added.
“The core objective of continuous bioprocessing is to link unit operations to create one-piece flow, and single use offers the appropriate connected flow path solutions to enable these solutions.”
The Cadence BioSMB Process equipment itself is not disposable, having a stainless steel structure, but contains a number of single-use components including pump heads and a valve cassette.
“The fluid is in contact with the biocontainer being used, and discarded after use, while for a traditional system the fluid would be in direct contact with the stainless steel creating exceptional cleaning and validation requirements in downtime,” said Levison.
The tech itself can also be used for semi-continuous and batch bioprocesses, but he added there are more benefits when Pall’s continuous unit operations are linked together.
“We have some very specific enabling technologies for end-to-end single use continuous operations that rival firms do not have. Our critical focus is on removing the bottlenecks we see in batch processes, making clarification and separation integrated, continuous operations.”