Greater than 97.0% as determined by SDS-PAGE.
Granulocyte-Colony Stimulating Factor (G-CSF) is a glycoprotein that plays a crucial role in hematopoiesis, the process by which blood cells are formed. It specifically stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. The recombinant form of G-CSF, produced using Chinese Hamster Ovary (CHO) cells, is widely used in clinical settings to treat neutropenia, a condition characterized by an abnormally low number of neutrophils, which are a type of white blood cell essential for fighting infections.
The discovery of G-CSF dates back to the early 1980s. It was first isolated from human cells by Malcolm Moore and Karl Welte in 1984 . The human form of G-CSF was cloned by research groups from Japan and Germany/United States in 1986 . This breakthrough led to the development of recombinant G-CSF, which has since become a cornerstone in the treatment of various conditions, particularly those related to cancer therapy.
Chinese Hamster Ovary (CHO) cells are a type of cell line derived from the ovary of the Chinese hamster. These cells are commonly used in biological and medical research due to their ability to produce large quantities of recombinant proteins. The production of recombinant G-CSF involves inserting the human G-CSF gene into CHO cells, which then express the protein. This method ensures a high yield and purity of the recombinant protein, making it suitable for therapeutic use.
Recombinant G-CSF is primarily used to treat neutropenia in patients undergoing chemotherapy or bone marrow transplantation. It helps to reduce the risk of infections by increasing the number of neutrophils in the blood . Additionally, G-CSF is used in the mobilization of hematopoietic stem cells for collection and subsequent transplantation. It has also shown promise in improving ovum quality and maturity in women with poor ovarian response undergoing in vitro fertilization (IVF) .
G-CSF binds to specific receptors on the surface of hematopoietic stem cells and granulocyte precursors in the bone marrow. This binding activates intracellular signaling pathways that promote the proliferation, differentiation, and survival of these cells. As a result, there is an increase in the production and release of neutrophils into the bloodstream .
The safety and efficacy of recombinant G-CSF have been well-documented in numerous clinical trials. It has been shown to significantly reduce the incidence of febrile neutropenia and other complications associated with low neutrophil counts in cancer patients . The use of pegylated forms of G-CSF, which have a longer half-life, has further improved patient outcomes by reducing the frequency of administration .
Research into G-CSF continues to evolve, with ongoing studies exploring its potential applications in other medical conditions and its role in enhancing the efficacy of existing treatments. Advances in biotechnology may also lead to the development of more efficient and cost-effective methods for producing recombinant G-CSF.