Chapter 33: Design and Development Considerations for Autoinjector Delivery Systems: Technology Developer and Industry Perspectives
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Design and development considerations for autoinjector (AI)-based combination products are described from both pharma company and device supplier perspectives. The importance of understanding patient needs and developing design inputs early is highlighted, and the typical feature sets of AIs and general usage steps are explained. Examples of currently marketed autoinjector-based combination products are listed for comparison. An holistic device technology and partner selection process is presented from a pharma company perspective. This process considers device technology as but one aspect that must be assessed, and many other collaboration factors that are critical for ensuring a predictable product development process are highlighted. The concept of platform autoinjectors is defined, and their advantages (relative to bespoke development) are explained in terms of development cost and efficiency. Future challenges of autoinjector design and development are framed relative to delivery of higher volumes of potentially more viscous drug product formulations, with improved usability. AIs with connectivity as an added feature for improved compliance and patient outcomes are just beginning to appear on the market, and this is expected to grow significantly in the future.
KeywordsAutoinjector Needle shield Sheath Drug product (DP) Platform Platform technology Partnership Partnership assessment Partner selection Cultural fit Technology landscaping Device target product profile (dTPP) Freedom to operate (FTO)
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