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Modeling the Downstream Processing of Monoclonal Antibodies Reveals Cost Advantages for Continuous Methods for a Broad Range of Manufacturing Scales
Author(s) -
Hummel Jonathan,
Pagkaliwangan Mark,
Gjoka Xhorxhi,
Davidovits Terence,
Stock Rick,
Ransohoff Thomas,
Gantier Rene,
Schofield Mark
Publication year - 2019
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201700665
Subject(s) - bioprocess , process engineering , biopharmaceutical , downstream (manufacturing) , process (computing) , computer science , biochemical engineering , manufacturing engineering , downstream processing , environmental science , engineering , operations management , microbiology and biotechnology , chemistry , biochemistry , chemical engineering , biology , operating system
The biopharmaceutical industry is evolving in response to changing market conditions, including increasing competition and growing pressures to reduce costs. Single‐use (SU) technologies and continuous bioprocessing have attracted attention as potential facilitators of cost‐optimized manufacturing for monoclonal antibodies. While disposable bioprocessing has been adopted at many scales of manufacturing, continuous bioprocessing has yet to reach the same level of implementation. In this study, the cost of goods of Pall Life Science's integrated, continuous bioprocessing (ICB) platform is modeled, along with that of purification processes in stainless‐steel and SU batch formats. All three models include costs associated with downstream processing only. Evaluation of the models across a broad range of clinical and commercial scenarios reveal that the cost savings gained by switching from stainless‐steel to SU batch processing are often amplified by continuous operation. The continuous platform exhibits the lowest cost of goods across 78% of all scenarios modeled here, with the SU batch process having the lowest costs in the rest of the cases. The relative savings demonstrated by the continuous process are greatest at the highest feed titers and volumes. These findings indicate that existing and imminent continuous technologies and equipment can become key enablers for more cost effective manufacturing of biopharmaceuticals.