Storage in Dosing and Administration Devices
Most biotech products may adhere to either plastic or glass containers such as syringes, polyvinyl chloride (PVC) intravenous bags, infusion equipment, and glass intravenous bottles. The effectiveness of the product may be reduced by three- or four-fold due to adherence. In order to decrease the amount of adherence, human serum albumin (HSA) is usually added to the solutions. The relative loss through adherence is concentration dependent, i.e., the more concentrated the final solution the less significant the adherence becomes. The amount of HSA added varies with the product (Banga and Reddy, 1994; Koeller and Fields, 1991). Some products that require the addition of HSA include filgrastim, sargramostim, aldesleukin, erythropoietin and inter-feron-a. In the case of filgrastim, the addition of 2 mg/ mL of HSA to the final solution is required for concentrations of 5 to 15 mg/mL (Amgen, 2004). One mg of HSA per 1 mL 0.9% Sodium Chloride injection is added to achieve a final concentration of 0.1% HSA for sargramostim concentrations of <10 mg/mL. (Berlex, 2004). For aldesleukin 0.1%, HSA is required for all concentrations (Chiron, 2000). For erythropoie-tin, 2.5 mg HSA is present per mL in each single-dose and multi-dose vial (Amgen, 2006). One mg/mL of HSA is added to interferon-a in single dose and multi-dose vials and pens (Schering, 2004).
For additional information or to find informa-tion for other products, check the current product information or contact the manufacturer.