Methods and formulations for reducing the agglomeration of the polymer under physiological conditions

2009 
The present invention is by adding polyvinylpyrrolidone having a molecular weight of 2,000 to 54,000 Daltons (PVP) 5% ~20%, for preventing large macromolecules, for example, reduction and condensation protein aggregation under physiological conditions to provide a method. The present invention further provides a method for minimizing the inflammation at the injection site during the subcutaneous administration of large macromolecules. In a further aspect, the present invention is a large pharmaceutical formulations for subcutaneous administration of the polymer, and, CD20 positive cancer or an autoimmune comprising administering a pharmaceutical formulation of the invention comprising a humanized anti-CD20 antibody It provides a method for the treatment of disease. The present invention further to evaluate the ability of excipients that reduce aggregation of the antibody or other large macromolecules under physiological conditions, provides an in vitro dialysis method.
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