Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Andrea Allmendinger, Prof Dr (she/her/hers)
Chief Scientific Officer
ten23 health AG
Grenzach-Wyhlen, Germany
Intravitreal (IVT) drug delivery presents unique challenges that require careful consideration throughout development and manufacturing. This talk will explore key aspects, starting with the fundamentals of IVT drug delivery and its specific formulation challenges, including viscosity and composition. The critical role of primary packaging material selection will be discussed focusing on usability and functionality, as well as key quality attributes such as particulate matter, container closure integrity (CCI), endotoxins, as well as external decontamination. Furthermore, the presentation will address best practices in the fill-finish processes ensuring product safety and compliance with regulatory requirements.
A core objective of this prologue session is to highlight the interplay between formulation composition and device properties, essential for achieving optimal performance. Additionally, compendial requirements for IVT injections will be reviewed ensuring alignment with industry and regulatory standards.
By the end of this presentation, you will gain a deeper understanding of the complexities in IVT drug product development and manufacturing.