Scale up is defined as the increase of a product in size, number or extent, according to a fixed ratio. For organizations scale-up may also refer to an increase in production or capacity. In the pharmaceutical industry formulation scale-up is the term used to refer to the increase in the batch size of pharmaceutical drug products.
If a pharmaceutical drug product is successful, then it may scale-up multiple times throughout its life cycle to meet growing demand. Eventually, scaling down may also happen in response to shrinking demand for drug products.
On the way from laboratory to market, scale-up is a part of product research and development (R&D) and optimization. Commercial batch manufacturing should be considered as a possibility when new formulations are in the R&D phase. Producing materials at a larger scale without performing small-scale experimentation is unreasonable as an overall tactic for modern pharmaceutical product development.
Years ago, scaling up pharmaceutical production of a new therapy was a linear, iterative process that demanded patience and deep pockets. Best practices, and more than a little trial and error, moved processes from the bench to the manufacturing floor.
Over the past decade, as manufacturing operations have become more complex, engineering advances in modeling, digitalization, single-use process equipment, and process intensification have made scale-up manufacturing more systematic, for drug products.
Scale-up manufacturing can be challenging and involves risk. However, small-scale process development, using appropriate equipment and applying well established guiding principles, mitigates risk using a material-sparing and resource efficient approach.
Contract services offered by fully integrated contract development and manufacturing organizations (CDMOs) include formulation scale up contract services from laboratory scales to pilot scales, and ultimately the commercial production scale.