Abstract: The present invention belong to the field of biotechnology, in particular to the field of galenics. The present invention is directed to an aqueous pharmaceutical composition comprising 1-50 mg/ml of a human or humanized full length IgG4, e.g. natalizumab, and a formulation selected from (i) to (iii), as further defined in the claims. The present invention is further directed to a method for producing said pharmaceutical composition, and medical uses thereof. Finally, also provided is a method for stabilizing human or humanized full length IgG4, e.g. natalizumab, as further defined in the claims.
Type:
Application
Filed:
May 19, 2021
Publication date:
April 21, 2022
Applicant:
POLPHARMA BIOLOGICS S.A.
Inventors:
Dariusz Mateusz Suchy, Malgorzata Bozena Tracka, Kornelia Bogumila Wisniewska, Michael Josef Safinowski, Klemen Spaninger, Piotr Marcin Zien
Abstract: The invention provide a method for reducing the amount of acidic species and/or increasing the amount of basic species in a composition comprising a recombinant protein or for increasing the specific production rate of mammalian cells expressing a recombinant protein to simplify subsequent clarification and purification of the recombinant protein, said method comprising culturing mammalian cells expressing said recombinant protein in a cell culture medium comprising citrulline.
Type:
Application
Filed:
June 8, 2018
Publication date:
June 25, 2020
Applicant:
Polpharma Biologics S.A.
Inventors:
Louis Boon, Lenneke De Winter, Tomasz Sitar