Abstract

 Background and Objectives

 Albumin is currently used in greater volume than any other biopharmaceutical solution that is available. The most large- scale production of human albumin is still conducted by cohn cold ethanol fractionation (Cohn's method). In order to save the operating time, labor and material in manufacturing albumin 20%, a two-stage process was carried out based on the cold ethanol fractionation method.

  Materials and Methods

 For this experimental study, fresh frozen plasma (FFP) was used as a starting material. In the first stage by addition of supernatant IV to a dissolved fraction V paste, a dense fraction V paste (Vd+I) containing the highest possible albumin concentration and the least impurity (ethanol, a globulins and ionic concentration) was recovered by centrifugation the recovered paste was then dissolved and filtered through a depth filter in order to remove a globulins as impurity. The filtrate (HPs) was suitable to produce albumin 20%. Two batches were produced and all the methods for the evaluation of the finished product were applied according to the guidelines of the British Pharmacopoeia.

 Results

 The quality control of the albumin 20% as a finished product from 2 batches (batches 1 and 2) in the final container produced by the proposed procedure led to satisfactory results. Appearance of the product was clear, purity over 99% , and the molecular size distribution of albumin was revealed for aggregates or polymers less than 2.7 % . The yield of albumin was 24 ± 1 gr/kg of plasma.

 Conclusions

 Advantages of the proposed process as compared with the rountine process (Cohn & Kistler- Nitschmann methods) during the production of intermediate products (Vd+I, HPs) were remarkable savings in terms of operating time, material and manpower at about 50%.

 Key words: Human serum albumin, Plasma fractionation, Cohn Fraction V