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To ensure product efficacy and safety, thorough characterization of protein aggregates throughout their product life cycle remains indispensable. To obtain diverse profiles of protein aggregates, orthogonal methodologies with different operating principles should be employed in combination, as each method has its own strengths and pitfalls. Starting with the end goal (quality standard, expressed quantitatively, ideally based on clinical information) and setting sampling plans to demonstrate that quality standard with specified levels of confidence, will mean that processes and methods can be developed statistically and intentionally to meet that standard. 2 OctOber 2024 Inhalation Inhalation (ISSN 1940-414X digital) is published seven times per year in January, February, April, June, August, October and December by Whipsnade and Loophole, LLC, P.O. Box 27092, Minneapolis, MN 55427 US. w w w . i n h a l a t i o n m a g . c o m October 2024 Volume 18 Number 5 devices 10 Analytical techniques for detecting and characterizing protein aggregates in inhaled formulations Michael Y. T. Chow and Jenny K. W. Lam 18 Issue focus: Devices 22 Point of view: A better way to set specifications and control quality—General concepts and examples Helen Strickland, J. David Christopher, Beth Morgan, Greg Larner and Svetlana Lyapustina outsourcing services 30 Special section: Outsourcing services additional features 6 Cross-industry organizations: RDD ® 2024 sets the bar for RDD Asia 2024 and RDD Europe 2025 The Organizers of the Respiratory Drug Delivery Conference Series 9 Previewing DDL2024 35 Back pages: FARE's Teen Advisory Group (TAG) pursues initiatives to support food-allergic community Books can teach and support young children managing allergies departments 8 Industry news 8 Respiratory medicine news 33 Calendar 34 Web review: White papers and webinars Cover photo shows the AB FIA critical flow controller TriggerBox III with the Next Generation Impactor and the S-Matrix Fusion Inhaler Testing Software Platform (FIT) for testing inhaled drug delivery devices. Courtesy of AB FIA, S-Matrix and CI Informatics.