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Copyright: © 2014 Shintani H. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. In case the technologies were developed that allowed biological or biotechnological materials to be produced in large quantities for pharmaceutical use, the opinion was heard in both sides of industry and regulatory circles that “the process is the product”. This perspective was based on the understanding that the main production agents produce large quantities of chemically similar materials that must undergo a variety of separation steps that can select the greatest yield of the highest purity of a desired molecular entity from the cellular-derived milieu. The separation processes used to sort out the one or more target proteins from other, often co-purifying, proteins are optimized, scaled, and validated to reliably achieve the same population of molecular entities from each batch of biologically produced material. The nature of these separation processes is such that even subtle changes in some steps can impart significant variations in the resulting population of proteins. It has been shown repeatedly that successfully defining and controlling the process can define and control the product, hence the rationale for the phrase [1].

Qualified and Validated Analytical Procedures for Pharmaceutical Products Majoring from Biological Origins