Successful Industrialization Requires Solid Foundations

By Jennifer Riter, Senior Director, Business and Technical Operations, and Victoria Morgan, Director, Biologics Marketing, West Pharmaceutical Services, Inc.

The increased complexity and cost associated with manufacturing innovative therapeutics—compounded by the increased scrutiny from regulatory authorities on the supply chain’s ability to deliver even greater levels of quality—are requiring containment system and drug delivery system manufacturers to develop components that not only ensure quality, safety, and efficacy throughout a drug product’s lifecycle, but also mitigate the risks and maximize the efficiencies of fill-finish processing.

Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the challenges associated with injectables – most notably extractables, leachables and particulates – which are some of the primary reasons for a product recall.