Removal of Bacteriophase phix174 From Protein Solutions Using Pvdf Ultrafiltration Membranes

摘要

The production of therapeutic proteins, by extraction from human and animal tissue and fluids and from continuously cultrued mammalian cells, ahs associated with it the risk of potential contamination by viruses. Viral contamination is a major problem, as current echniques for both the detection and the inactivation/removal of viruses leave much to be desired. Not all viruses are known and detected easily. New types f viruses or virus-like particles appear now and then. The current methods for virus inactivation, such as chemical, thermal, ultraviolet, and gamma-ray treatment, do not affect all viruses equally. The non enveloped viruses have proved ot be more resistant to the inactivation treatment, Also, as these physical and chemical methods allow the inactivated virus to remain within the product, recombinant incorporation of viral DNA/RNA is a concern (DiLeo et al 1992). With some techniques, protein stabilisation is required and any virucidal and/or stabilishing chemicals introduced during the process must the redced to safe levels n the final products.