Open AccessComparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor
Author(s) -
Beck Christian,
Werz Silke,
Herrmann Alexander,
Meiringer Christoph T. A.
Publication year - 2020
Publication title -
engineering reports
Language(s) - English
Resource type - Journals
ISSN - 2577-8196
DOI - 10.1002/eng2.12197
Subject(s) - bioreactor , comparability , monoclonal antibody , process engineering , quality (philosophy) , product (mathematics) , production (economics) , critical quality attributes , computer science , biochemical engineering , quality by design , manufacturing engineering , microbiology and biotechnology , reliability engineering , new product development , engineering , antibody , business , mathematics , chemistry , biology , immunology , geometry , macroeconomics , organic chemistry , epistemology , combinatorics , marketing , economics , philosophy
Single‐use bioreactors (SUB) and stainless steel bioreactors (SSB) differ in their physical properties. This can have an effect on the performed processes. To be able to guarantee flexible planning in a facility, any kind of processes in SUB and SSB must be sufficiently similar. To date, assessments of SUB and SSB have been exclusively specific for one single product. This study shows a general nonproduct‐specific comparison of the production of different types of monoclonal antibodies in different scales of SUBs and SSBs. The study is set up with 72 clinical manufacturing fermentation runs in total by comparing the cell culture performance and quality attributes of these two bioreactor systems. The outcome is that SUBs and SSBs can produce monoclonal antibodies with comparable cell culture performance and product quality. This general comparability paves the way for SUBs to produce new and existing products for (clinical) manufacturing.