Late-phase development of biologics is both the most time-intensive and costly stage of drug development. This is due, in large part, to the challenge of developing a drug product with maximum end-to-end stability whilst complying with complex country-specific regulations in preparation for market authorization. Guided by a clearly defined target product profile, it is crucial to devise a cross-functional holistic development strategy that takes manufacturing, patient administration and final market presentation into consideration.
In this webinar it is discussed the challenges of this complex path to commercialization. Watch it to learn more about the important role of pharmaceutical development to ensure a robust drug product, the distinct requirements of development of combination products, as well as the importance of having systematic and structured process technology transfers for successful drug product launches.