For biological products, a product license software or modification should be submitted and permitted earlier than a new MCB may be generated from a WCB. Occasionally, trusted amino acids manufacturer a new MCB could also be generated from a WCB. For stationary vessels, usually clean-in-place (CIP) apparatus may be encountered. The doc was reviewed and expanded upon during a 2 l/2 day workshop (May 29-3l, l99l) attended by the next Center and Field personnel: Wendy Aaronson (CBER), Henry Avallone (NWK- DO), Yuan-Yuan Chiu, Ph.D. Removal of nucleic acid at each step within the purification process may be demonstrated in pilot experiments by examining the extent of elimination of added host cell DNA.
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