Medimmune Limited

Astrazeneca Ab

Jared Samuel Bee

Liu Tie

David Edwin Gruber

Christopher Douglas Afdahl

Roberto Depaz

Richard Edward Turner

Natalie DeJesus

Described herein is a method for separating a recombinantly produced polypeptide from host cell protein. The method includes a step of loading a clarified cell culture supernatant that includes the recombinantly produced polypeptide and the HCP onto a Protein A chromatography column and washing the Protein A chromatography column with a wash buffer comprising a fatty acid having a chain length of at least about 6 carbon atoms, or a fatty acid salt thereof to remove HCP and then recovering the recombinantly produced polypeptide.

Purification of recombinantly produced polypeptides

The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti-INFAR1 antibody. In some embodiments, the invention relates in general to a stable antibody formulation comprising about 100 mg/mL to about 200 mg/mL of an antibody or fragment thereof that specifically binds human interferon alpha 1 (INFAR1); about 20 mM to about 80 mM of a lysine or a salt thereof; about 0.02% to about 0.06% of a surfactant; an uncharged excipient; and a formulation buffer. In some embodiments, the invention is directed to a container, dosage form and/or kit. In some embodiments, the invention is directed to a method of making and using the stable antibody formulation.

Stable anti-IFNAR1 formulation

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Gaithersburg, MD, United States of America

Jared Samuel Bee