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Volume 32, Issue 11
The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.
Scale-down principles have long been used to evaluate and understand how a process will be carried out and the parameters that surround the process. In particular, scale-down models are used to conduct evaluations on how a process should be scaled for commercial production and to give an understanding of the design space that would be needed, according to Diane Blumenthal, head, technical operations, Spark Therapeutics.
The use of scale-down models allows for processes to be optimized theoretically and for troubleshooting problems during the developmental stage, and before bringing the processes to full scale. Understanding the design space around processes is important as the processes get closer to licensure. With a scale-down model, process developers and manufacturing associates can evaluate the parameters by which a process would run correctly. At the same time, it would give them an idea of whether or not the process would still run and give the same quality results if certain parameters where a bit off.
“That means that we want to be running down the middle, but we want to know that if we run to the left or run to the right a little bit, will the process still perform the same, and is the product at the end still going to meet all the attributes that we need it to meet?” Blumenthal explains.
A scale-down model allows process developers and manufacturing associates to establish a range within which the process can be deemed to be on course. During production, operators need to know when a parameter has fallen out of range and to know when a point of failure will happen.
“We never want to run close to the point of failure. We tell the operations team to run somewhere at the midpoint and provide them with boundaries on either side of the midpoint. Without scale-down models, it is hard to do that level of work quickly, efficiently, and cost effectively,” says Blumenthal.
Vol. 32, No. 11
When referring to this article, please cite it as F. Mirasol, “The Principle of Scaling Down,” BioPharm International 32 (11) 2019.