At the 2024 PDA Annual Meeting, experts from Kindeva Drug Delivery presented our insights on injectable and intradermal drug-device combination products. Spanning holistic design for aseptic injectable fill-finish, human factors for autoinjectors, and manufacturing of microneedle array patches (MAPs), our posters showcase our latest developments and know-how across injectable drug delivery. If you missed any of our presentations, download your copies to discover our wide range of expertise.
Posters include:
Holistic Design Principles That Collectively Meet the Need of the Current Market and Regulators Tomorrow and Over the Horizon
Chad Hafer
- The importance of risk reduction in aseptic manufacturing through a contamination control strategy (CCS) and Annex 1 compliance
- An overview of automation and technology to improve operations, including restricted access barriers systems (RABS), isolators, robotic systems, rapid/alternative methods, continuous monitoring systems, and no-touch transfers
- Benefits of virtual reality and 3D modeling for placement of equipment, building layout, ergonomic concern, and process steps
Breaking Out of the Human Factors Study Loop, for the Benefit of Patients
Amy M. Lukau
- An evaluation of select finding from autoinjector human factor studies, demonstrating best practices and justification of risk mitigation
- Creation of a Use Related Risk Analysis (URRA), leveraging end user and use environment analysis to define cases, tasks, and subtasks related to the user interface, potential use errors, the potential harm to the user from these errors, and severity of that harm
- Benefits of implementing URRA early in the HFE process to lay the foundation for a systematic, streamlined approach
Manufacturing in Miniature: Drug Delivery via Microneedle Array Patches (MAPs)
Tim Peterson & Andy Riso
- Potential benefits of MAPs over a syringe and needle
- Challenges in developing scalable manufacturing processes for MAPs and efforts undertaken to address these concerns through Quality by Design (QbD) principles
- The positive impacts of using phase-appropriate processes at the lab, pilot, and commercial scale for microneedle array manufacturing
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