Aggregation of a monoclonal antibody induced by adsorption to stainless steel

Stainless steel is a ubiquitous surface in therapeutic protein production equipment and is also present as the needle in pre-filled syringe biopharmaceutical products. Stainless steel microparticles can cause the aggregation of a monoclonal antibody (mAb). The initial rate of mAb aggregation was sec...

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Bibliographic Details
Published in:Biotechnology and bioengineering 2010-01, Vol.105 (1), p.121-129
Main Authors: Bee, Jared S, Davis, Michele, Freund, Erwin, Carpenter, John F, Randolph, Theodore W
Format: Article
Language:English
Subjects:
Adsorption
Antibodies, Monoclonal - chemistry
Biological and medical sciences
Biotechnology
Fundamental and applied biological sciences. Psychology
Humans
kinetics
Mass Spectrometry
mechanism
Monoclonal antibodies
monoclonal antibody
Oxidation
protein aggregation
Proteins
Stainless steel
Stainless Steel - chemistry
Surface Properties
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Summary:Stainless steel is a ubiquitous surface in therapeutic protein production equipment and is also present as the needle in pre-filled syringe biopharmaceutical products. Stainless steel microparticles can cause the aggregation of a monoclonal antibody (mAb). The initial rate of mAb aggregation was second order in steel surface area and zero order in mAb concentration, generally consistent with a bimolecular surface aggregation being the rate-limiting step. Polysorbate 20 (PS20) suppressed the aggregation yet was unable to desorb the firmly bound first layer of protein that adsorbs to the stainless steel surface. Also, there was no exchange of mAb from the first adsorbed layer to the bulk phase, suggesting that the aggregation process actually occurs on subsequent adsorption layers. No oxidized Met residues were detected in the mass spectrum of a digest of a highly aggregated mAb, although there was a fourfold increase in carbonyl groups due to protein oxidation. Biotechnol. Bioeng. 2010;105: 121-129.
ISSN:0006-3592
1097-0290
DOI:10.1002/bit.22525