Biotech‐based therapeutics have emerged as the growth engine for the pharmaceutical industry. Successful development and commercialization of biotech processes require the understanding of the relationships between the various attributes of the product and the product's clinical safety and efficacy, as well as, the effect of the different process parameters on the product's attributes. The complexity of the biotech products and the requirement for rigorous experimentation justify working at small scales.
This article presents general guidelines and relevant parameters affecting scale‐down of the various unit operations involved in purification of proteins. The key parameters, assessment methods, assessment techniques, and challenges involved in scale‐down are discussed.