Recombinant G-CSF (rG-CSF)

Cerbios recombinant G-CSF is a glycoprotein obtained by rDNA technology from a CHO cell line, in advanced stage of technical development. The next step will be to find partners and proceed to non-clinical and clinical testing.

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 clinics for the reduction of severity and duration of neutropenia associated with cytotoxic therapy or bone marrow transplantation.

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 the FDA.

Intellectual property

The drug substance is biosimilar to Lenograstim.

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