Biotherapeutics remain the largest growing segment in the pharmaceutical industry, spurred by various technological advancements in many fields and with further progress in understanding diseases. Moreover, advanced therapy medicinal products (ATMPs) offer ground-breaking new opportunities for the treatment of currently untreatable diseases or provide for additional effective and curative treatment options.
These advances in pharmacotherapy are also giving challenges and hurdles, with regulators becoming increasingly stringent. It is critical to consider potential interactions with primary packaging components and direct contact materials. The importance of pre-filled syringes and other pre-filled drug containers, often used in combination with drug delivery devices, cannot be underestimated within this space of parenteral drug delivery.
This workshop will address various aspects regarding potential influences from primary packaging components and materials on drug quality, safety and efficacy, including the influence of sub-visible particles, extractables and leachables, silicone oil, handling and manipulation, e.g. aggregation, protein degradation routes and stability.
This workshop will bring together experts from academia, the pharmaceutical industry and providers of primary packaging components to share their experiences. There will be plenty of time allocated for discussion and interaction with the audience.