Implementation of advanced technologies in commercial monoclonal antibody production.
Process advancements driven through innovations have been key factors that enabled successful commercialization of several human therapeutic antibodies in recent years. The production costs of these molecules are higher in comparison to traditional medicines. In order to lower the development and later manufacturing costs, recent advances in antibody production technologies target higher throughput processes with increased clinical and commercial economics. In this review, essential considerations and trends for commercial process development and optimization are described, followed by the challenges to obtain a high titer cell culture process and its subsequent impact on the purification process. One of these recent technical advances is the development and implementation of a disposable Q membrane adsorber as an alternative to a Q-packed-bed column in a flow-through mode. The scientific concept and principles underlining Q membrane technology and its application are also reviewed.
Zhou
Joe X
JX
Process and Product Development, Amgen, Inc., Thousand Oaks, CA 91320-1799, USA. joez@amgen.com
Tressel
Tim
T
Yang
Xiaoming
X
Seewoester
Thomas
T