A special elution buffer system for significantly removing half-antibody fragment impurities in double antibody culture

By using a special elution buffer and rinsing technique in the affinity chromatography step, the problem of removing semi-antibody fragment impurities in bispecific antibody culture was solved, achieving high-purity bispecific antibody purification that meets commercial production standards.

CN122404472APending Publication Date: 2026-07-17INTELLECTIVE BIOLOGICS (SUZHOU) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
INTELLECTIVE BIOLOGICS (SUZHOU) CO LTD
Filing Date
2026-05-28
Publication Date
2026-07-17

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Abstract

The application discloses a special elution buffer system for significantly removing half-antibody fragment impurities in double-antibody culture and belongs to the technical field of biology. In the elution stage of the eluent in the affinity chromatography capture, the application adds ammonium sulfate to the eluent, removes the half-antibody fragment, improves the purity of the target protein after the affinity chromatography, and makes the purity of the double-antibody meet the demand of a medicine (the SEC-HPLC purity is greater than 97%) after the purification. By using the elution system method, the purity of the half-antibody fragment nr-CE is reduced from 6% to 0.2%.
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