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Designing an Artificial Golgi reactor to achieve targeted glycosylation of monoclonal antibodies
Author(s) -
Klymenko Oleksiy V.,
Shah Nilay,
Kontoravdi Cleo,
Royle Kate E.,
Polizzi Karen M.
Publication year - 2016
Publication title -
aiche journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.958
H-Index - 167
eISSN - 1547-5905
pISSN - 0001-1541
DOI - 10.1002/aic.15388
Subject(s) - glycosylation , biopharmaceutical , monoclonal antibody , quality by design , throughput , process engineering , pellets , process (computing) , computer science , chemistry , biochemical engineering , engineering , chemical engineering , materials science , antibody , microbiology and biotechnology , biology , biochemistry , immunology , telecommunications , composite material , particle size , wireless , operating system
The therapeutic efficacy of monoclonal antibodies (mAbs) is dependent on their glycosylation patterns. As the largest group of currently approved biopharmaceuticals, the microheterogeneity in mAb oligosaccharide profiles deriving from mammalian cell production is a challenge to the biopharmaceutical industry. Disengaging the glycosylation process from the cell may offer significant enhancement of product quality and allow better control and reproducibility in line with the Quality‐by‐Design paradigm. Three potential designs of an Artificial Golgi reactor implementing targeted sequential glycosylation of mAbs are proposed including a (1) microcapillary film reactor, (2) packed bed reactor with nonporous pellets, and (3) packed bed reactor with porous pellets. Detailed mathematical models are developed to predict their performance for a range of design and operational parameters. While all three reactor designs can achieve desired conversion levels, the choice of a particular one depends on the required throughput and the associated cost of enzymes and co‐substrates. © 2016 The Authors AIChE Journal published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers AIChE J , 62: 2959–2973, 2016