Merck Sharp + Dohme Corp.

Sujatha Gomathinayagam

Piotr Bobrowicz

Stephen Robin Hamilton

Stefan Wildt

Natarajan Sethuraman

Terrance A Stadheim

Huijuan Li

Methods for producing proteins and glycoproteins inthat lack detectable cross binding activity to antibodies made against host cell antigens are described. In particular, methods are described wherein recombinantstrains that do not display a &#x3b2;-mannosyltransferase 2 activity with respect to an N-glycan or O-glycan and do not display at least one activity selected from a &#x3b2;-mannosyltransferase 1, 3, and 4 activity to produce recombinant proteins and glycoproteins. These recombinantstrains can produce proteins and glycoproteins that lack detectable &#x3b1;-mannosidase resistant &#x3b2;-mannose residues thereon and thus, lack cross binding activity to antibodies against host cell antigens. Further described are methods for producing bi-sialylated human erythropoietin inthat lack detectable cross binding activity to antibodies against host cell antigens.

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Hanover, NH, United States of America

Sujatha Gomathinayagam