Description
Erythropoietin is a glycoprotein, which stimulates red blood cell production. In healthy individuals, it is produced in the kidney and stimulates division and differentiation of committed erythroid progenitors in the bone marrow.
Recombinant Human Erythropoietin (rHu EPO), also called as Epoetin alpha, a 165 amino acid protein with a molecular mass of 30.6kDa. The rHu EPO of Intas Biopharmaceuticals is produced by mammalian cells into which the human erythropoietin gene is introduced. The product contains identical amino acid sequence of natural Erythropoietin.
rHu EPO is used clinically for treatment of anemia of Chronic Renal Failure Patients, anemia in Zidovudine-treated HIV-infected Patients, anemia in Cancer Patients on Chemotherapy and reduction of Allogeneic Blood Transfusion in Surgery Patients.
Manufacturing process
Erythropoietin, manufactured by Intas Biopharmaceuticals, is produced in genetically engineered CHO cells. The product is expressed and secreted into medium. After cell culture, medium is harvested and product is purified by a series of chromatographic steps to produce highly purified Erythropoietin.
The finished product (Erykine® & Epofit®) is manufactured by formulating the Erythropoietin drug substance into Citrate buffer with other excipients.
Available Dosage Forms
Erykine® is available in pre-filled, preservative free, single dose syringe containing 10,000 Units/mL (Erykine 10K) and 40,000 Units/mL (Erykine 40K) and is targeted for Treatment of Anaemia in Cancer Patients on Chemotherapy.
Epofit ® is available in pre-filled, preservative free, single dose syringe containing 2,000 Units/mL (Epofit 2K) and 4,000 Units/mL (Epofit 4K) and is targeted for Chronic Renal Failure Patients.
Current regulatory status:
Presently, Erykine®
Product quality
The product undergoes comprehensive physicochemical characterization and testing as per European Pharmacopoeia (EP) by methods such as Isoelectric Focusing, Western Blotting, Gel Electrophoresis, Mass Spectrometry, N-terminal Sequencing, Peptide Mapping, In-vivo Bioassay and the product is found to be identical to the reference standard.
The activity and purity in terms of unrelated impurities (host protein and nucleic acids from CHO cells) as well as related impurities such as aggregates and other variants is comparable to that of the reference standard. The CHO cell-derived impurities are at PPM levels are in conformance with WHO and EMEA norms.
PRODUCTS
