INHALATION DRUG DELIVERY ARTICLES

25_DDL_Regulatory_Reconnaissance_logo_color GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products

In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

INHALATION DRUG DELIVERY VIDEOS

Stephen Stein, scientific director of inhalation products at Kindeva, joins Supplier Horizons host Tom von Gunden in a discussion of opportunities and challenges for inhalation product development. The topics discussed include ensuring bioequivalence in generics, reducing environmental impact from propellants, and advancing inhalation-based delivery of vaccines and combination therapies.

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.

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at delivery device consultancy Suttons Creek and formerly at FDA, provides an overview of the evolution of regulations and standards that have been developed for and/or applied to drug delivery technologies over the years.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 8 on post-market lifecycle management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Khaudeja Bano.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • 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.

  • Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • 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.

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

  • Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.

  • Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.

  • 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.