Recombinant granulocyte colony stimulating factor (filgrastim) of prolonged action: Optimization of conditions for extraction and purification from inclusion bodies

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.