Alderbio Holdings LLC

Alder Biopharmaceuticals, Inc.

Hoa Binh Do

John A Latham

Leon F Garcia-Martinez

Ethan Wayne Ojala

Daniel S Allison

Mark Young

Leon F Garcia-martinez

Geoffrey F Lee

Steven D Davin

Processes for producing and purifying recombinant proteins are disclosed. In particular, the present disclosure provides processes of producing and purifying multi-subunit proteins expressed in yeast or filamentous fungal cells. The production and/or purification of such proteins are monitored for impurities, preferably using lectin binding assays, such that one or more process parameters may be adjusted to maximize the amount of desired recombinant protein and minimize the amount of glycosylated impurities. The processes can also be monitored for other undesired product-associated impurities, such as aggregates and nucleic acids. In exemplary embodiments, the recombinant proteins are multi-subunit proteins, such as antibodies, the host cell is a yeast, such as, and the glycosylated impurity is a glycovariant of the desired recombinant polypeptide, such as an N-linked and/or O-linked glycovariant.

Antibody purification and purity monitoring

Growing community of inventors

Kirkland, WA, United States of America

Hoa Binh Do