Enabling advanced TPPs for Biosimilars – When Formulation Expertise and Data Science Join Forces
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Keynote
Room 1
T&I Technology & Innovation
- Although the demonstration of similarity between a biosimilar and its corresponding originator product remains a key prerequisite, there is a clear trend towards designing new features into biosimilar drug products.
- These features may enable reduced cost of goods, facilitated supply chains or improved convenience for patients and health care professionals (HCPs).
- Aligning this with the objective of biosimilarity together with a significant need for speed wihtin the course of product development also drives the need for new and more rationalized approaches towards formulation development.
- Data science has shown to be a key enabler in this process. Advanced data mining, design of experiments as well as predictive approaches to formulation design and expedited demonstration of adequate shelf-life will play a fundamental role in biosimilar development of the future and may also be a reponse to increasing competition in the field.
Andreas SeidlChief Scientific OfficerFormycon AG