From purification of drug substance to delivery to the patient
One of the key issues that is currently preventing self-administration of viscous injectable formulations is that the drug delivery device technologies needed to facilitate easy administration have not been readily available. The devices required to allow patients to deliver such formulations need to ensure that the needle is fine enough to ensure the patient is comfortable but also wide enough to deliver viscous material by applying the minimum amount of force . However, several new technologies now exist that can deliver highly viscous formulations through surprisingly fine needles. That being said, there remains some significant hurdles to overcome in order to make these mediations readily available to patients and the focus now also has to be shifted upstream to the challenges with both the drug product and drug substance.
In this presentation Andrew Donnelly, VP of Innovation and Alastair Willoughby, Development Manager at Bespak by Recipharm will discuss the key considerations and challenges when developing viscous formulations for parenteral administration, including, drug substance manufacture, drug product stability, fill/finish requirements and device mediated drug delivery.
In the presentation our team will also cover the drug delivery device technologies that Bespak by Recipharm has developed to address the challenges faced with viscous formulation, as well as outline the other areas that should be considered during the development of products with these characteristics.
Presented by
Andrew Donnelly,
VP Innovation
Andrew is Vice President of Innovation at Bespak by Recipharm. With 25 years of experience in the pharmaceutical industry and a PhD in drug delivery, Andrew is responsible for leading the Bespak by Recipharm innovation team of engineers and scientists and working to identify needs for new technologies. As part of his role, Andrew is also responsible for creating and identifying new solutions, as well as working with the biopharmaceutical industry to develop combination products.
Alastair Willoughby,
Development Manager
Alastair is a Mechanical Engineer by training and worked within product development consulting, primarily focusing on medical devices, before joining Bespak in 2012 . Since joining the Innovation Group Alastair has been heavily involved with the development of several drug delivery devices and platform technologies. Alastair works with many project teams across the Innovation group as well as the wider Recipharm organisation to support transfer of these programmes into manufacturing.
