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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