The branch of biotechnology that focuses on the development and commercialization of medicines for several of the civilized world's severe diseases, such as cancer immune disorders, and vaccines for preventive or pandemic applications, the so-called red biotechnology, has grown tremendously since 1979 when the first biologic was approved. The biotechnology industry has experienced unprecedented success over the past few decades. The custom affinity resins not only address the need for a capture resin for non-platformable processes, but also can be employed in polishing applications, where they are used to define and control drug substance composition by separating specific product variants from the desired product form. These concepts are discussed from a growing field of custom affinity bioprocess resin perspective. The use of AC can result in economic advantages by enabling the standardization of process development and the manufacturing processes and the use of continuous operations in flexible multiproduct production suites. The objective of this mini-review is to provide an overview of a) the history of bioprocess AC, b) the current state of platform processes based on affinity capture steps, c) the maturing field of custom developed bioprocess affinity resins, d) the advantages of affinity capture-based downstream processing in comparison to other forms of chromatography, and e) the future direction for bioprocess scale AC. Affinity chromatography (AC) has been used in large-scale bioprocessing for almost 40 years and is considered the preferred method for primary capture in downstream processing of various types of biopharmaceuticals.
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