Hematopoietic growth factor, recombinant

Here, an overview of biopharmaceutical products thus far approved (within the EU and US at least) is presented. The products have been grouped into nine categories recombinant blood factors, recombinant thrombolytics, recombinant insulins, additional recombinant hormones, recombinant hematopoietic growth factors, recombinant IFNs and ILs, recombinant vaccines, monoclonal and engineered antibodies, and additional biopharmaceuticals (e.g., cell therapy, gene therapy, siRNA). 

SCF (recombinant product ancestim) is an early-acting hematopoietic growth factor that stimulates the proliferation of primitive hematopoietic and nonhema-topoietic cells [7]. In vitro, SCF has minimal effect on hematopoietic and nonhematopoietic progenitor cells, but it synergistically increases the activity of other hematopoietic growth factors, such as G-CSF, GM-CSF, and EPO. SCF stimulates the generation of dendritic cells in vitro and mast cells in vivo. 

The use of recombinant hematopoietic growth factors (i.e., the commercially available forms of the native products) has been evaluated in many disorders affecting all types of blood cells. Recombinant human hematopoietic growth factors are identified as rHu. Not all uses discussed have received regulatory approval in all countries. 

When hematopoietic growth factors are used clinically, they can be associated with adverse effects. Very often patients who require hematopoietic growth factors are quite ill with their disease (i.e., cancer or kidney failure) or from their treatment (i.e., chemotherapy) and it is difficult to determine if a recombinant growth factor is responsible for a given side effect. Both rHuG-CSF and rHuGM-CSF are associated with mild-to-moderate... 

The recombinant hematopoietic growth factors have had a significant impact on the treatment of cancer, including prevention of serious infections and anemia. 

Siefl) C.A., Introduction to recombinant hematopoietic growth factors. UpToDate Online, 2002.10(2). 

Erythropoietin, a 34-39 kDA glycoprotein, was the first human hematopoietic growth factor to be isolated. It was originally purified from the urine of patients with severe anemia. Recombinant human erythropoietin (rHuEpo, epoetin alfa) is produced in a mammalian cell expression system... 

Figure 18.2 illustrates a graded dose-effect relationship for recombinant human erythropoietin (rhEPO) in patients with end-stage renal disease (2). Erythropoietin/ which is produced by the kidney in response to hypoxia/ is a naturally occurring hematopoietic growth factor that stimulates bone marrow production... 

Recombinant hematopoietic growth factors consist of several EPOs and colony-stimulating factors (Table 5). EPO represents the single most lucrative biopharmaceutical of... 

Recombinant Antihemophilic Factor VIII 424 Recombinant blood factor 9 Recombinant factor VIII (rFVII) 420,459 Recombinant HB 1422 Recombinant hematopoietic growth factor 15 Recombinant hepatitis B surface antigen (rHBsAg) 3... 

Hematopoietic growth factors also have been produced in mammalian cell cultures by recombinant DNA techniques. Erythropoietin can be used in certain types of anemias to stimulate the production of red blood cells. Colony-stimulating factors (CSFs) and interleukins (ILs) can be used after bone marrow transplants and after chemotherapy to stimulate white blood cell production and decrease the risk of infection. 

B. Other Blood Cell Deficiencies Deficiency in the concentration of the various lineages of blood cells can be a manifestation of a disease or a side effect of radiation or cancer chemotherapy. Recombinant DNA-directed synthesis of hematopoietic growth factors now makes possible the treatment of more patients with deficiencies in erythrocytes, neutrophils, and platelets. Some of these growth factors also play an important role in stem cell transplantation. 

All of the recombinant hematopoietic growth factors approved for clinical use are administered by injection. 

Recombinant DNA technology provides a powerful tool for new pharmaceutical product development and production. Table 6.4 lists the rDNA-produced drugs and vaccines approved by the U.S. FDA through the year 2000. The biotech products include hormones, enzymes, cytokines, hematopoietic growth factors, other growth factors, blood clotting factors and anticoagulants, and vaccines. 

Laver, J., and M.A.S. Moore Clinical Use of Recombinant Human Hematopoietic Growth Factors. J. Nat. Cancer Inst. 81, 1370 (1989). 

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