Abstract: The disclosure relates to a preparation and purification method for an antibody drug conjugate intermediate, and more particularly relates to a preparation and purification method for a linker part and drug part conjugate in an antibody drug conjugate, which can not only effectively remove impurities from a target product and by-products in a reaction process, making the purity of the target product finally obtained up to 99% or above, but also realize stable mass production and well meet the quality standard requirements of clinical drugs, so as to provide a tremendous guarantee for drug safety and stable supply.

Abstract: Provided is a preparation and purification process of MMAE. The process has mild synthesis and purification conditions, can effectively prevent the change of product chirality caused by excessively high temperature, greatly reduces generation of degradation impurities, and increases the purity and yield of the product. In addition, the preparation and purification process has good stability and is more suitable for scale-up production. The MMAE prepared has purity of higher than 99%, and can perfectly meet clinical drug requirements.

Abstract: Disclosed is a pharmaceutical formulation containing a mixture of a non-reducing sugar, a TACI-Fc fusion protein and at least one amino acid. The pharmaceutical formulation has the characteristics of reducing particulate matter, reducing aggregate formation, improving the stability, improving the appearance of a freeze-dried powder, etc.

Abstract: The invention relates to a pharmaceutical formulation comprising a mixture of a non-reducing sugar, a recombinant humanized anti-Her2 monoclonal antibody-MMAE conjugate, and a surfactant. The pharmaceutical formulation has characteristics of reduced particulate matter, reduced aggregates, improved stability of the conjugate, improved appearance of the lyophilized powders and the like.

Abstract: Disclosed are an anti-HER2 antibody and conjugate of the anti-HER2 antibody and small molecule medicine. Also disclosed are uses of the antibody and conjugate thereof in preparing medicine for treating tumor.