A Scale-up is an important concept in pharmaceutical and biopharmaceutical manufacturing industry.
In the pharma industry, scale up refers to the process of increasing the production from laboratory-scale to commercial-scale manufacturing.
This transition involves several important steps and considerations to ensure that the product can be consistently and efficiently produced in larger quantities while maintaining its safety, quality, and efficacy.
It is defined as to take a biopharmaceutical manufacturing process from the laboratory scale to a scale at which it is commercially feasible.
It is to increase the size of something whilst maintaining proportion or to change a process in order to allow for greater quantities.
Laboratory-scale batches are those that are made when the drug is still being tested from its time in the lab to clinical trials.
The next level is pilot-scale which may be for the purpose of expanding clinical trials, or for mid- to later stage clinical evaluation.
Pilot-scale is usually about 10% of the production-scale, which is also known as commercial scale. When a drug is approved and in demand it will be produced at the commercial-scale batch size. If demand increases, production may be expanded to other facilities and in some cases to other countries.
