Affinity Chromatography: An Enabling Technology for Large‐Scale Bioprocessing

• Published in: Biotechnology journal 2020-01, Vol.15 (1), p.e1800397-n/a
• Main Authors: Łącki, Karol M., Riske, Frank J.
• Format: Article
• Language: English
• Subjects: affinity; Animals; Biological Products; bioprocess; Biotechnology; Cell Culture Techniques; chromatography; Chromatography, Affinity; continuous operation; custom resins; facility platform; Humans
• ISSN: 1860-6768; 1860-7314
• DOI: 10.1002/biot.201800397

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. 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. 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. These concepts are discussed from a growing field of custom affinity bioprocess resin perspective. 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. Affinity chromatography makes purifying biological molecules simpler and straight forward, makes manufacturing and process development faster and more efficient, allows companies to build one facility, whereas in the past, many facilities were necessary, and enables continuous chromatography operations. These benefits can now be realized also for targets that could not be be purified using catalog affinity resins.