Recovery of Albumin from Cohn Fraction IV Using Immobilised Procion Blue-BB: Development of a Full Scale Production Process.
The high capacity, high specificity and relatively low cost of the pseudo-affinity adsorbent, Procion blue HB-Sepharose CL 6B, has been exploited in the development of a production scale system for the recovery of human albumin from Cohn Fraction IV and other albumin containing source materials. Whilst the system has been established for the purification of albumin, other applications such as provision of albumin-depleted plasma fractions for use in the purification of α1-antitrypsin and transferrin have followed.
The highly reproducible chromatographic characteristics of the adsorbent have allowed the process to be readily scaled-up through laboratory and pilot scale to the final production system. Optimisation of the coupled ligand concentration for the production scale adsorbent (40L bed volume) allowed a capacity of greater than 25mg albumin per ml adsorbent to be achieved without compromising product purity or process characteristics.
The system has been adapted to computer controlled automation which has permitted multiple cycles to be carried out without supervision. Processing conditions relevant to the industrial application of this full scale process eg. adsorbent regeneration, sterilization and pyrogen-free operation have been defined. The application of specific and non-specific albumin desorption conditions has further served to demonstrate the versatility of the system in that minor plasma proteins, eg. growth factors can be fractionated by a two-step elution procedure.
KeywordsAutomate Process Control Sodium Octanoate Cohn Fraction Pyrogen Free Water Full Scale Process
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