Inventors:
Brian Lobo - Clarksburg MD, US
Sabrina Lo - San Francisco CA, US
Aditya Wakankar - San Francisco CA, US
Yuchang John Wang - Los Altos CA, US
Rita L. Wong - Redwood City CA, US
Pierre Goldbach - Rixheim, FR
Hanns-Christian Mahler - Basel, CH
International Classification:
A61K 39/395
A61P 35/00
A61P 19/02
G01J 3/00
A61P 29/00
A61P 17/06
A61P 3/10
A61P 35/02
A61P 25/00
Abstract:
The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.
