08.16.22 -- Assessing Risk And Reducing Complexity For Drug Delivery

There is still confusion on the extractables and leachables topic, since guidances, where available, do not give step by step instructions on testing. Plus, drug products and other drug product contact materials are getting increasingly more complex. So, where should you start?

Gain a comprehensive rundown of where biosimilar sponsors stand and the key issues ahead of market formation. Explore how the largest loss of exclusivity (LOE) event in the U.S. pharma market will usher in a new era of much-needed biosimilar competition for anti-TNF biologics.

Theoretical calculations can provide insight into how much a drug component will interact with delivery system materials. Predicting these interactions can enable scientists to exclude potentially problematic excipients and select the right packaging solution for their specific formulation.

Because of competitive pressures, generic manufacturers are under considerable influence to get their products to market quickly. Discover how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.

An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.