Biopharmaceutical drugs, also known as biologics, have become an essential part of modern pharmacotherapy and include examples such as biological proteins, cytokines, hormones, monoclonal antibodies, vaccines, and celland tissue-based therapies. Biopharmaceuticals may include compounds such as biosimilars, molecules meant to be an improved version of a previously developed drug on which the patent has expired.
The hematopoietic colony-forming cell (CFC) or colony-forming unit (CFU) assay can be used to test the activity of can be used to test the activity of biopharmaceutical cytokines. Hematopoietic progenitors are isolated from human bone marrow, and plated in a CFU assay to observe the direct stimulatory effects of test articles on progenitor growth and morphology. The effects of these cytokines can be similarly evaluated in animal models. For example, the data below show the effects of erythropoietin (EPO) measured in vitro ( Figure 1, Table 1 ) and in vivo ( Figure 2, Table 2 ), and of granulocyte-stimulating factor (G-CSF) ( Figure 3 ). Hematopoietic progenitors are isolated from human bone marrow, and plated in a CFU assay to observe the direct stimulatory effects of test articles on progenitor growth and morphology. The effects of these cytokines can also be evaluated in animal models.