Amongst the new processes and changes in biomanufacturing in the last few years is the ever-growing presence of disposable systems. As industry continues to move towards the single-use, the design of a plant – both new and old - has had to adapt.
“Single-use bioprocess technology has been evolving for the past decade, providing increasing potential to reduce the capital costs associated with conventional hard-piped stainless steel piping and vessels,” said Michael Anderson, the Executive VP and COO of Total Facility Solutions (TFS).
He told Biopharma-Reporter.com that the technology “will likely present continued opportunities as the pressure continues to reduce capital and operating costs,” as firms look to benefit from single-use to in such applications as reducing cross-contamination and cleaning validation.
This sentiment was echoed by Michael Cicio - VP Operations Pharma & Biotech at Lonza Biologics – who told us in his experience disposable technology is already widely used in the design and construction of plants:
“It can be used to help adapt existing facilities to improve quality compliance or operations,” he said, and “it can also be incorporated to facilitate new products, or as part of new small scale facility design to reduce the overall capital cost by reducing utility and start-up costs.”
Size Constraints
Cicio also told us of how single-use is being taken up by small clinical facilities who use “modular self-contained systems, which do not require large footprints and require minimal support systems.”
However, for larger production, “whole disposable suites have been implemented for both upstream and downstream processing,” there may be some volume throughput constraints, he said. “Therefore many stainless steel facilities are using disposables to adapt their facilities to varied production processes.”
Anderson added disposable technology has so far been limited due to scale (typically under 2000L), and though there have been recent developments to provide disposable applications for larger fermenters and bioreactors, “validation of materials in contact with the product are still being evaluated.”