Amgen Inc.

Chetan Goudar

Henry Lin

Jonathan Lull

Sean Cole

Nicole Sabo

Tharmala Tharmalingam

Rohini Deshpande

Nicole Le

Hedieh Barkhordarian

Ricaredo Matanguihan

Yan Wang

Natalia Gomez

Medhi Saghafi

Jonathan Craig Lull

The present invention provides a continuous upstream manufacturing process for the production of bispecific antibody products, which comprise at least two binding domains. The process comprises at least the steps of (i) providing in a perfusion bioreactor at least one mammalian cell culture, which is capable of expressing the bispecific antibody product, (ii) growing the mammalian cell culture at a first perfusion rate until a set point viable cell density is reached, and (iii) maintaining perfusion culture at a second perfusion rate, wherein the bispecific antibody product concentration in the bioreactor is kept below a threshold value. The bispecific antibody product is then subject to subsequent downstream processing. Moreover, the invention provides a bispecific antibody product produced by the continuous upstream manufacturing process.

Continuous manufacturing process for bispecific antibody products

The invention provides methods and materials for culturing mammalian cells and harvesting recombinant protein.

Methods for harvesting mammalian cell cultures

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Newbury Park, CA, United States of America

Chetan Goudar