English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

Filgrastim is classified as a biopharmaceutical and it is the cytokine G-CSF (Granulocyte-Colony Stimulating Factor) human recombinant protein. The biological effect of this cytokine G-CSF is mainly related to the proliferation and differentiation of granulocytes, which are important cells in host defense against many microorganisms. Neutropenia caused by chemotherapy or as a consequence of diseases are widely treated with this recombinant protein. Filgrastim is part of the list of drugs that can be purchased by the brazilian health system (SUS) and this medicine will soon be produced at Fiocruz. The relationship between potency and efficacy of recombinant proteins is very strong and any variations in this respect may compromise the wished effect in patients. Moreover, physicochemical assays alone does not assure the pharmacological effect of this type of substance. Therefore, quality control procedures must be designed to confirm the biological effect and be performed routinely. Currently, there is no method in the national pharmacopoeia for this biopharmaceutical. In the European Pharmacopoeia, the pharmacological potency is recommended to be determined by an in vitro assay performed in M-NFS-60 cell line and is based on the evaluation of proliferative potential, as mesured by MTT metabolization. This cell line, however, has some disadvantages such as: the need for supplementation with M-CSF and it is a mouse cell line.

Kasumi-1 cell line: an alternative to the potency assay of Filgrastim biopharmaceutical