TORONTO – JUNE 24, 2021 – As a combination drug product development project moves from the laboratory into production to generate supplies for clinical research, it is necessary to involve multiple functions including manufacturing, engineering and analytical support to make and release these materials. This is especially true for inhalation and nasally administered powders. The complexity of transferring a drug product is increased when the product involves a drug-device combination.
In this webinar, the speakers will examine what you need to know about your product to effectively support these transitions, including understanding the target product profile, critical quality attributes, product and device variability, analytical testing, regulatory requirements and the interaction of testing and manufacturing parameters. Similarly, the receipt, inspection and assembly of the device components will be discussed within the context of their impact on device efficiency, and thereby their effect on product delivery and performance. Aspects of device evaluation will also be discussed in terms of performance and more routine testing such as assays.
Register for this webinar to learn about critical steps to transfer the development process, sponsor and service provider responsibilities and an efficient framework to collaborate with partners will be presented to help minimize delays and accelerate timelines on your pathway to the clinic.
Join Justin Lacombe, Chief Scientific Officer, Experic LLC; and Julie D. Suman, President, Scientific Affairs, Next Breath, an Aptar Pharma company, for the live webinar on Tuesday, July 13, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Combination Drug Products: A Development Roadmap to Clinical Trials.