For new biologics and drug development, the quicker a company can get its product to patients, the better. Combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.
This webinar reviews the impact of the most recent regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.
Design of experiment (DoE) is the centerpiece of analytical quality by design. Explore our DoE assay development pipeline approach, which delivers optimized, robust, and rugged analytical methods ready for method qualification.
Catalent Biologics is your one integrated partner with the expertise to get your biologics to market faster. We have the passion to help you accelerate, simplify, and de-risk your biologics from development and manufacturing to fill/finish, to clinical supply, and commercial launch.