Livzon Mabpharm Inc.

Yucai Peng

Baoguo Zhu

Qiang Li

Lee-Hwei King Sun

Zhenxiang Hu

Bill Nai-Chau Sun

Cecily Rou-Yun Sun

Jiaming Yang

Ruey Shyan Liou

Desheng Tao

Jingwei Zhang

The present invention provides a method for determining glycosylation and terminal modifications of immunoglobulin during immunoglobulin purification process, which can simultaneously and rapidly determine glycosylation, N-terminal pyroglutamination and C-terminal de-lysination of immunoglobulin, including Step 1) separating immunoglobulin by using cation-exchange resin, and collecting different components in according to retention time; Step 2) denaturing the components of immunoglobulin obtained in step 1) with a denaturant, followed by reducing them with a reducing agent, to separate the light chain and heavy chain; Step 3) separating the light chain and heavy chain of immunoglobulin of step 2) by using reverse phase ultrahigh pressure liquid chromatography; Step 4) measuring the molecular weights of the light chain and heavy chain obtained in step 3) with mass spectrum; and Step 5) analyzing the chromatographic data obtained in step 3) and the mass spectrometric data obtained in step 4) to determine glycosylation and terminal modifications of the immunoglobulin.

Method for determining glycosylation and terminal modification of samples during protein purification process

The present invention provides a humanized anti-TNF monoclonal antibody and the use thereof. The humanized anti-TNF monoclonal antibody significantly reduces the immunogenicity of murine-antibody while retaining the ability of antibody to recognize antigen, compared with conservative mouse chimeric antibody. Therefore, safety of the antibody in clinical applications has been improved.

Humanized anti-TNF&#x3b1; antibodies

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Guangdong, China

Yucai Peng