November/December 2004 Issue
Manufacturing's input is critical where questions of solubility, stability and delivery are concerned.
A Pfizer public education campaign and its cute mascot are praiseworthy, but neglect to mention the key stage in a drug's life. What will it take to make manufacturing a hot button issue and to better educate the public?
Is a cell culture capacity shortage likely? Biomanufacturers are still scratching their heads.
Batch automation standards are having an impact far from the control room, changing approaches to plant design, specification, and validation
Simulated moving bed chromatography, widely used in chiral separations, can also be used to remove structurally similar impurities from target APIs.
Microreactors and micro-scale equipment enable faster, continuous reactions, and are starting to make their mark in pharmaceutical manufacturing.
The last word on PAT extends its use from a manufacturing to a cradle-to-grave tool for gaining process knowledge, FDA’s Ajaz Hussain says.