Remove Communication Remove Pharmaceutical Companies Remove Process Improvement
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Considerations for a successful tech transfer of a biologics upstream process

European Pharmaceutical Review

The emergence of huge pharmaceutical companies with discrete centres of excellence in geographically dispersed locations has upended the classic model of one-stop shopping for all development functions. Having a person in plant for some tech transfers facilitates higher levels of communication.

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An Evaluation of Postapproval CMC Change Timelines

ISPE

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Consequently, comparing results across companies and through time will establish an increasingly robust perspective of trends in global approval durations.