Lecture Notes 14 Process Control Assays

Lecture Notes 14 Process Control Assays - Quarantined raw...

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Unformatted text preview: Quarantined raw matls Media and buffer prep Released raw matls Cell expansion and prodn bioreactor Isolation, purification Formulation, fill, and finish BASIC LAYOUT OF PLANT Utilities: PW, WFI, clean steam, etc Assays for monitoring water quality Assays for releasing incoming raw matls - identity testing, Assays for monitoring environment: bioburden in air, on surfaces In-process assays for control of process: bioburden, product conc, impurity levels, Assays for validating CIP, SIP. Assays for releasing equipment for changeover from product A to product B Assays for releasing product - identity, purity, bioactivity, concentration, excipient levels, Quarantined product Released product...
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This note was uploaded on 08/09/2011 for the course CHEN 4820 at Colorado.

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Lecture Notes 14 Process Control Assays - Quarantined raw...

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