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Bioorg Khim ; 40(5): 550-9, 2014.
Article in Russian | MEDLINE | ID: mdl-25895350

ABSTRACT

We developed a unified process platform for two recombinant human GCSF medicines--one with the non-prolonged and the other with prolonged action. This unified technology led to a simpler and cheaper production while introduction of the additional pegylation stage to the technological line eased obtaining of the medicines with different action and allowed to standardize technological process documenting according to GMP requirements.


Subject(s)
Granulocyte Colony-Stimulating Factor/isolation & purification , Inclusion Bodies/chemistry , Neoplasms/drug therapy , Recombinant Proteins/chemistry , Drug-Related Side Effects and Adverse Reactions , Febrile Neutropenia/chemically induced , Febrile Neutropenia/pathology , Filgrastim , Granulocyte Colony-Stimulating Factor/chemistry , Granulocyte Colony-Stimulating Factor/genetics , Granulocyte Colony-Stimulating Factor/therapeutic use , Humans , Neoplasms/complications , Neoplasms/pathology , Polyethylene Glycols/chemistry , Recombinant Proteins/genetics , Recombinant Proteins/isolation & purification , Recombinant Proteins/therapeutic use
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