Novel method to sterilize recombinant products
OwnerAlan I Rubinstein, Daniel P. Rubinsteininventors
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Abstract
Recombinant proteins, manufactured with genetic engineering techniques, like its counterpart human derived proteins, for example, recombinant Factor VIII have the potential for transmission of viruses and bacteria which are used in the process. This invention demonstrates that one may dry heat at high temperature, the lyophilized final Factor VIII product even at high temperatures and still show significant VIII:C activity. Such terminal dry heat will assure that there has been recontamination.
Claims6
A method to inactivate any microorganism or virus in a genetic manufactured product by lyophilizing and then heating at a predetermined temperature and time at a predetermined pressure until there is significant microbiologic or viral inactivation.
Dependencies are inferred from the claim text.