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PERSPECTIVE ON PHARMA: From the factory
Scaling up
T
he rapid transition from drug development to full-scale production is crucial for biopharmaceutical manufacturers to realise a return on their R&D costs. Speed to market requires the efficient scaling up of a manufacturing process—whether it occurs in the same facility or moves to a new one. The adoption of singleuse systems (SUS), with their flexibility, portability, and ease of use, makes them the obvious cost-effective solution for scaling up. SUS accommodates increased demand, whether this occurs during development or only once full-scale production becomes necessary. Most importantly, incorporating SUS into R&D pilot processes makes it more efficient to scale up to commercial production.
The popularity of singleuse bioprocessing solutions continues to grow, with the market in the biopharma industry projected to be worth $26.89 billion by 2025, with a compound annual growth rate of 13.6%.1 Replacing traditional bioprocessing equipment with continually improving single-use technology and the expansion of single-use manufacturing Mark A. Sitcoske, founder & CEO of High Purity New England (HPNE) explains the benefits of using single-use systems to scale up from development to full-scale production in biomanufacturing facilities.
facilities by contract manufacturing organisations (CMOs) are key contributors to this growth. Demand is also being driven by its spread upstream and downstream into all areas of biopharmaceutical manufacturing, from research and development to fill-finish. While the shift to SUS has
revolutionised bioprocessing and manufacturing facilities, scaling up from discovery and development to fullscale manufacturing can be a challenge for biopharmaceutical manufacturers. Challenges include the need to design and implement a new process for commercial production
that may differ from laboratory conditions. Fortunately, innovations in single-use systems equipment and processes, along with vendor partners who can design, engineer, and build a fully customised solution, are helping companies that are looking for solutions.
