Biotech Products - Neukine

Product Description :
Description
Recombinant Human Granulocyte Colony Stimulation Factor (rHu G–CSF), also called as Filgrastim, is a 175 amino acid protein with a molecular mass of 18.8 kDa. The protein is manufactured by recombinant DNA technology using E. coli. The rHu G-CSF of Intas Biopharmaceuticals, Neukine®, is identical to natural human G-CSF except it has an additional methionine at the N-terminal end and is unglycosylated, matching the active ingredient of the innovator’s product.

G–CSF stimulates the survival, proliferation, differentiation and function of neutrophil granulocyte progenitor cells and mature neutrophils. RHu G–CSF is used clinically for prevention and treatment of chemotherapy-induced neutropenia.
Manufacturing process
Neukine® is produced in genetically engineered E. coli. The product is expressed in the form of inclusion bodies (insoluble aggregates inside the bacterial cell). After fermentation, the bacteria are lysed, and the inclusion bodies are isolated, the protein is folded and the product is purified by a series of chromatographic steps.
The finished product (Neukine®) is manufactured by formulation into Acetate buffer.
Composition
Neukine® is available in pre-filled syringe containing 300 mcg (30 MioU) of G–CSF /ml in Acetate buffer containing Sorbitol and Polysorbate 80 at pH 4.0.
Current regulatory status
Presently, Neukine® is marketed in India. Registration dossiers for marketing approval are available as per CTD format.
Product Quality
The product undergoes comprehensive physicochemical characterization by methods such as Isoelectric Focusing, Western Blotting, Gel Electrophoresis, Mass Spectrometry, N–terminal Sequencing, Peptide Mapping and product is seen to be identical to the reference standard. The activity and purity in terms of unrelated impurities (host protein and nucleic acids from E. coli) as well as related impurities such as aggregates and other variants is comparable to that of the reference standard. The E. coli-derived impurities are at PPM levels are in conformance with WHO and EMEA norms.