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Chapter: Pharmaceutical Biotechnology: Fundamentals and Applications - Dispensing Biotechnology Products: Handling, Professional Education, and Product Information

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Temperature Requirements - Pharmacist Reluctance

Since biotech products are primarily proteins, they are subject to denaturation when exposed to extreme temperatures.

Temperature Requirements

Since biotech products are primarily proteins, they are subject to denaturation when exposed to extreme temperatures. In general, most biotech products are shipped by the manufacturer in gel ice containers and need to be stored at 2LC to 8LC (Banga and Reddy, 1994). Once reconstituted, they should be stored under refrigeration until just prior to use. There are a few exceptions to this rule. For example, alteplase (tissue plasminogen activator) lyophilized powder is stable at room temperature for several years at temperatures not to exceed 30LC (86LF). However, after reconstitution, the product should be used within 8 hours (Genentech, 2005). For individual product temperature requirements, the product insert, product website or the manufacturer should be contacted. Table 3 lists temperature requirements for selected frequently prescribed products.

  


The variability between products with respect to temperature is exemplified by granulocyte-colony sti-mulating factor (G-CSF, filgrastim; Amgen, 2004) and erythropoietin (Amgen, 2006), which are stable in ready-to-use form at room temperature for 24 hours and 14 days, respectively. Granulocyte macrophage-colony stimulating factor (GM-CSF, sargramostim; Berlex, 2004) is packaged as a lyophilized powder, but still requires refrigeration and once reconstituted is stable at room temperature for 30 days or in the refrigerator for 2 years. Aldesleukin (interleukin-2) is stable for 48 hours at room temperature or under refrigeration (Chiron, 2000). Betaseron (interferon-b1b) must be stored in a refrig-erator and should be used within three hours after reconstitution (Berlex, 2003). While most products require refrigeration to maintain stability due to denaturation by elevated temperatures, extreme cold such as freezing may be just as harmful to most products. The key is to avoid extremes in temperature whether it is heat or cold (Banga and Reddy, 1994).


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