R. Christian Moreton

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

Change is inevitable, as is contract manufacturing. But which companies will survive the drifts?

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.