Product case study Neupogen

Neupogen (tradename, also known as filgrastim) is a recombinant G-CSF first approved for medical use in the USA in 1991. It is indicated for the treatment of neutropenia associated with various medical conditions, often in cancer patients undergoing chemotherapy. The 175 amino acid, 18.8 kDa protein is produced in engineered E. coli and is identical to native human G-CSF except for (a) the presence of an additional methionine residue at the molecule's N terminal end and (b) the absence of glycosylation. Both differences are a consequence of expression in E. coli. Production entails cell growth and harvest, followed by product extraction and purification using several chromatographic and ultrafiltration procedures. It is presented as a sterile solution in either single-use vials or pre-filled syringes and contains acetate buffer, sorbitol and Tween 80 as excipients.

Details of administration vary according to exact indication, but it is administered by s.c. or i.v. infusion daily, usually for several days at dosage levels of 5-10 |g kg-1 day-1. Peak plasma concentrations are usually observed within 2-8 h after s.c. administration and the drug's elimination half-life ranges between 2 and 5 h. The product is used in conjunction with cancer chemotherapy in one of two ways: prophylactically, to prevent neutropenia onset, or therapeutically, to reverse established neutropenia. Numerous clinical trials have been undertaken with various cancer patient types, and the product has generally been shown to be safe and effective in accelerating neutrophil count recovery following various chemotherapeutic regimes. The product was found to reduce the median number of days of severe neutropenia observed in patients with severe chronic neutropenia, acute myeloid leukaemia and non-myeloid malignancies who receive myeloblative chemotherapy followed by bone marrow transplant.

Commonly reported side effects include bone and muscle pain. Serious (sometimes life threatening) but rare side effects have included splenic rupture and adult respiratory distress syndrome. Neupogen is manufactured and marketed by Amgen Inc.

G-CSF and GM-CSF have also found application after allogenic or autologous bone marrow transplantation, to accelerate neutrophil recovery. (Allogenic means that donor and recipient are different individuals, and autologous means that donor and recipient are the same.)

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