Aggregation of a monoclonal antibody induced by adsorption to stainless steel.
Aggregation of a monoclonal antibody induced by adsorption to stainless steel.
复制标题
通过吸附到不锈钢引起的单克隆抗体的聚集。
DOI：
10.1002/bit.22525
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发表时间：
2010-01-01
影响因子：
3.8
通讯作者：
Randolph, Theodore W.
中科院分区：
文献类型：
--
作者：
Bee, Jared S.;Davis, Michele;Freund, Erwin;Carpenter, John F.;Randolph, Theodore W.
不锈钢是治疗性蛋白质生产设备中普遍存在的表面，并且还作为针头存在于一些预充式注射器生物制药产品中。不锈钢微粒可引起单克隆抗体（mAb）的聚集。mAb聚集的初始速率在钢表面积中为二阶，在mAb浓度中为零阶，通常与作为速率限制步骤的双分子表面聚集一致。聚山梨酯20（PS20）抑制聚集，但不能解吸吸附到不锈钢表面的牢固结合的第一层蛋白质。此外，没有mAb从第一吸附层到体相的交换，表明聚集过程实际上发生在随后的吸附层上。在高度聚集的mAb的消化物的质谱中未检测到氧化的Met残基，尽管由于蛋白质氧化，羰基增加了5倍。
Stainless steel is a ubiquitous surface in therapeutic protein production equipment and is also present as the needle in some pre-filled syringe biopharmaceutical products. Stainless steel microparticles can cause of 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 five-fold increase in carbonyl groups due to protein oxidation.
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影响因子：
3.8
作者：
Bee, Jared S.;Chiu, David;Randolph, Theodore W.
通讯作者：
Randolph, Theodore W.
影响因子：
3.8
作者：
Tyagi, Anil K.;Randolph, Theodore W.;Carpenter, John F.
通讯作者：
Carpenter, John F.
影响因子：
4.6
作者：
Soenderkaer, S;Carpenter, JF;Frokjaer, S
通讯作者：
Frokjaer, S
影响因子：
3.8
作者：
Alford, John R.;Kendrick, Brent S.;Randolph, Theodore W.
通讯作者：
Randolph, Theodore W.
影响因子：
2.9
作者：
Griffiths, SW;Cooney, CL
通讯作者：
Cooney, CL