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Controlled conductivity at low pH in Protein L chromatography enables separation of bispecific and other antibody formats by their binding valency.


ABSTRACT: The complex molecular formats of recent therapeutic antibodies, including bispecific antibodies, antibody fragments, and other fusion proteins, makes the task of purifying the desired molecules in a limited number of purification steps more and more challenging. Manufacturing these complicated biologics can be substantially improved in the affinity capture stage if the simple bind-and-elute mode is accompanied by targeted removal of the impurities, such as mis-paired antibodies and oligomers or aggregates. Here, we report a method, based on the binding valency to Protein L resin, of separating proteins during the elution step by simply controlling the conductivity at low pH. We show that the method efficiently separated targeted antibodies from mis-paired and aggregated species. Notably, the number of Protein L binding sites can be built into the molecule by design to facilitate the purification. This method may be useful for purifying various antibody formats at laboratory and manufacturing scales.

SUBMITTER: Chen C 

PROVIDER: S-EPMC6601544 | biostudies-literature | 2019 May/Jun

REPOSITORIES: biostudies-literature

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Controlled conductivity at low pH in Protein L chromatography enables separation of bispecific and other antibody formats by their binding valency.

Chen Chen C   Wakabayashi Tetsuya T   Muraoka Masaru M   Shu Feng F   Wei Shan Chia C   Chor Kun Chong C   Tim Jang Ching C   Soehano Ishin I   Shimizu Yuichiro Y   Igawa Tomoyuki T   Nezu Jun-Ichi JI  

mAbs 20190321 4


The complex molecular formats of recent therapeutic antibodies, including bispecific antibodies, antibody fragments, and other fusion proteins, makes the task of purifying the desired molecules in a limited number of purification steps more and more challenging. Manufacturing these complicated biologics can be substantially improved in the affinity capture stage if the simple bind-and-elute mode is accompanied by targeted removal of the impurities, such as mis-paired antibodies and oligomers or  ...[more]

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