Freezing pharmaceutical bulk: Preparing for scale-up
Scalability is another critical consideration for freezing processes in biosimilar production – but one that, at some point, is inevitable for many manufacturers. There are numerous reasons why these considerations are best made early on in process development, as the necessary equipment requires significant investments. Modular and scalable solutions have therefore entered the market, being able to smoothly transition from small to large scale.
Scaling pharmaceutical freezing, though, does not only refer to an increasing number of individual items to be processed, but also to their respective volumes. Freezing pharmaceutical bulk comes with its own set of challenges, such as achieving homogeneous freezing results.
Single Use Support has made these considerations while developing its freeze-thaw platform based on single-use technologies. Their modular platform design allows for flexible expansion, accommodating varying batch sizes and production volumes with ease, while transferring freezing protocols to larger units.
By using the plate freezing platform RoSS.pFTU, for instance, the direct contact between cooling plates and the packaging surface allows controlled and even freezing processes for various volumes – from 1 ml up to 500 L, depending on the chosen system. This scalability ensures that freezing processes can evolve in tandem with production demands, minimizing disruptions and maximizing productivity.
Scalability was not only a core idea at the conception of plate and cryogenic freezers, but rather for all process solutions developed by Single Use Support – such as fluid management solutions for biosimilar production, storage and transport systems. This enables manufacturers to establish highly automated biomanufacturing processes with minimal need for human intervention, enhanced safety and cost efficiency.