Recombinant G-CSF

Biological division

CERBIOS - PHARMA SA

Synonyms

Recombinant human Granulocyte colony stimulating factor
Lenograstim

 

Background and use

This drug substance is a cytokine with similar structure and function to the naturally occurring human G-CSF.
The biological function of G-CSF consists in the stimulation of proliferation and maturation of granulocytes and monocytes within the bone marrow. G-CSF is used in clinic for the reduction of severity and duration of neutropenia associated with cytotoxic therapy or bone marrow transplantation.
Cerbios recombinant G-CSF is a glycoprotein obtained by rDNA technology from a CHO cell line, in advanced stage of technical development. Next step will be to find partners and proceed to non-clinical and clinical testing.

 

Regulatory compliance

The manufacturing technology makes use of chemically defined, serum free, protein free media; no growth factors or antibiotics are added. All the components of media and solutions are certified to be of non-animal origin. The technology used in house has already been presented, during the development of another product, to FDA.

Intellectual property

The drug substance is biosimilar to Lenograstim.