INHALATION DRUG DELIVERY ARTICLES

GettyImages-2158404004-auto-injector-medicine Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?

In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).  

INHALATION DRUG DELIVERY VIDEOS

In this episode of Supplier Horizons, host Tom von Gunden talks with Chief Commercial Officer Christian Jones of nanoparticle technology developer Nanoform about innovation in drug and biologics delivery. The discussion covers aspects of patient centricity such as aging populations, in-home self-administration, and personalized medicine. It also focuses on the use of nanotechnology in the delivery of high concentration formulations via oral and subcutaneous routes of administration. 

In a special episode of In Combination, host Tom von Gunden visits the Graduate School of Pharmaceutical Sciences and the Nanomedicine Manufacturing Laboratory at Duquesne University. There, a professor and some graduate students share insights into the program’s focus on innovating nanoparticle formulation, manufacturing, and delivery. The coverage illuminates the role of academic, industry, and government partnerships in advancing the science and technology of nanomedicines toward clinical translation. 

To what extent are approaches to conducting risk assessments specified in the FDA URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers context-setting perspective on what FDA is looking for when reviewing URRA compliance.

Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.

  • Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.

  • Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.

  • Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.

  • A focused look at how low‑GWP propellant technologies support sustainability goals while preserving inhaler performance, offering guidance for planning regulatory readiness, device compatibility, and long‑term respiratory portfolio strategy.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.

  • Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.