Starting Your Sterile Injectables Program Off On The Right Foot
By Jennifer Quint and Daniel Lenz, Pfizer CentreOne
The successful sterile fill and finish of injectable drugs requires the highest levels of operational and quality excellence. Many variables must be considered and few cGMP manufacturing environments are as tightly controlled.
Due to growing demand, the pharmaceutical industry’s need for sterile injectable (e.g., aseptic and terminal sterilization fill/finish) capacity will likely grow, as will the role of contract development and manufacturing organizations (CDMOs) in delivering such capacity.1
How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Product development experts Jennifer Quint and Daniel Lenz at Pfizer CentreOne offer their tips on how drug sponsors and developers can put programs on a firmer footing.
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