In this webinar, we will explore the development of a 2nd generation downstream process for a complex biotherapeutic and discuss strategies to significantly reduce the number of unit operations, increase yields, reduce costs, and accelerate time-to-market while meeting CQA specifications.
Data generated throughout a medicine’s CMC development journey is often fragmented, siloed and lacks context - causing regulatory bottlenecks, manufacturing delays, and ongoing quality issues. During this discussion, panelists explore the criticality of data visibility in the CMC journey and learn practical strategies to improve data management, contextualization, and integrity.
Tech transfer is fraught with challenges, and it's crucial to have a solid understanding of the process, as well as, modern strategies for success. Our experts review challenges, discuss proven strategies for successful tech transfer, and highlight how VLE Therapeutics takes a unique approach to tech transfer through a focus on digitalization, process optimization, and risk management.
Faster development despite rising stereochemical complexity! In this webinar, Brendan Roche, PhD reviews engineering strategies which can be applied to key unit operations (e.g. crystallization, isolation etc.) of enantiomers and diastereomers of varying stereochemical complexity.
Speed development without comprising on quality! In this webinar, Hasbullah Daud, PhD discusses PAT, modelling, and cutting-edge analytical techniques to accelerate the development of this pioneering therapeutic modality.
Do you wish you could improve the efficiency of delivering genes to cells? Learn how employing mechanistic modelling + CFD to understand and optimize transfection and transduction efficiency can increase yield and lower costs.