Tuesday, November 6, 2012

Dispensing biotech products considering temperature requirements and storage in dosing and administration devices

Pharmaceutical Biotechnology
  Biotechnology refers to the application of biological systems, living organisms, or their derivatives in making or transforming products or processes for specific use.
 Pharmaceutical Biotechnology Products
The common pharmaceutical biotechnology products that are made by the biotech pharmaceutical companies include, 1.Antibodies e.g. monoclonal antibodies 2. Proteins 3.Recombinant DNA Products.
 Dispensing of Biotechnology Products 
Biotechnology products are proteins subject to denaturation and thus require special handling techniques. While (hospital) pharmacists are skilled in handling parenteral products, biotechnology products may provide additional challenges.
 Storage of Biotech products
  Biotech products have particular storage requirements. The shelf life of these products is often considerably shorter than for conventional compounds. Example, Interferon- α 2a is only stable in a refrigerator in the ready-to-use solution for 12 months. Since most of these products need to be kept at refrigerated temperatures.
 Temperature Requirements 
Since biotech products are basically proteins, they are subject to denaturation when exposed to excessive temperatures. In broad-spectrum, most biotech products are to be stored at 2–8 °C under refrigeration . Exceptions to this rule as exemplified by Alteplase (tissue plasminogen activator). Alteplase is stable at room temperature for several years. Aldesleukin (interleukin-2) is stable for 48 hours at room or normal temperature or up to 18 months in a refrigerator. Betaseron (interferon β-1b) must be stored in a refrigerator and should be used within three hours after reconstitution. While a large amount products require refrigeration to maintain stability due to denaturation by elevated temperatures, extreme cold such as freezing. 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 etc. 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. Those products requiring the addition of HSA include aldesleukin, erythropoietin and interferon a.

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