Technical Report No. 41 (Revised):
Virus Retentive Filtration, provides a summary of best practices for utilization
of virus filtration in process development and manufacturing. The document
explains what virus filters are and where they can be used in current and
emerging bioprocesses. Recommendations for selection of a suitable virus filter
are presented that include information on their physical and biological/safety
characterization and guidance on how to incorporate quality by design (QbD)
principles into virus filtration applications. Strategies for evaluating and
validating virus retention by virus filtration, including defining the
worst-case test parameters, are also discussed. Finally, considerations that
reflect best practices and current thinking for implementing virus filtration
into novel manufacturing technologies, such as barrier filters, continuous
bioprocessing modes for filtration, or production of ATMPs, are also included.
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