Process validation for cell culture-derived pharmaceutical proteins.
Principles of process validation are extremely powerful tools in assurance of product quality. They are especially useful for reducing those risks not easily measured routinely during production. When combined with effective process and facility design principles, characterization of cell banks and products, appropriate lot release tests, and adherence to cGMP, safe cell culture biologicals can be prepared in a reliable manner.
SmithKline Beecham Pharmaceuticals, King of Prussia, Pennsylvania.
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Lubiniecki
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ME
Wiebe
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Builder
D000818:Animals; D002460:Cell Line; D046508:Culture Techniques / Q000379:methods* / Q000592:standards; D004247:DNA / Q000302:isolation & purification; D005285:Fermentation; D006801:Humans; D011994:Recombinant Proteins / Q000302:isolation & purification / Q000592:standards*; D012307:Risk Factors
D011994:Recombinant Proteins; D004247:DNA