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Process improvements and in-person monitoring help U.S. pharmaceutical company achieve on time for Phase III clinical trials

Impact Pharmaceutical Services

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. Download The Case Study The post Process improvements and in-person monitoring help U.S.

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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

To ensure an efficient process, MyMD works closely with the contract manufacturing organisation (CMO) focusing on automation and process improvement. All pharmaceutical companies want to save on the cost of production, but not at the expense of quality. This allows us to stay on top of quality control.

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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. An example of the structured and modular tech transfer approach is shown in Figure 2.

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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.