Inhalation Drug Delivery Videos

  1. The Role of ISO 13485 in the New QMSR 7/11/2024

    What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

  2. URRA And UFMEA: Together Or Separate For Combination Products? 12/11/2024

    Both uFMEA (Use Failure Mode Effects Analysis) and URRA (Use-Related Risk Analysis) tools are available during combination product development for conducting risk assessments related to human factors. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss scenarios in which a uFMEA might be used to inform a URRA regulatory submission.

  3. From Powder To Particles With Jet Milling

    Gain valuable insights into the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.

  4. An EDDO Identification Tutorial For A Prefilled Syringe (PFS) 4/23/2025

    In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.

  5. Pathways For Pulmonary Delivery

    As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.

  6. LNP-Delivered mRNA via Inhalation with Ethris' Carsten Rudolph and Thomas Langenickel 9/18/2024

    How can genetic information be carried into lung tissue for the treatment of asthma and potentially other conditions? In this inaugural episode of In Combination, host Tom von Gunden combines the perspectives of two executives from LNP/mRNA (lipidoid nanoparticle / messenger RNA) formulation and delivery platform developer Ethris: CEO Carsten Rudolph and Chief Medical Officer Thomas Langenickel. The conversation illuminates the value to patients of platform approaches to inhalation-delivered treatments.

  7. Management Responsibility and the New QMSR 7/11/2024

    What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies underscores the criticality of management commitment to and engagement in the process.

  8. Integrating Development Processes For Combination Products 1/27/2025

    The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.

  9. How To Identify And Differentiate Combination Products 11/18/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 2 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor and Chapter 2 author, Susan Neadle. Considering both product development and the global regulatory landscape, the discussion focuses on answers to the question posed by the chapter title, “What Is a Combination Product?”

  10. Dry Powder Inhaler Services

    We offer comprehensive solutions for Dry Powder Inhalers (DPIs), encompassing all stages from initial formulation screening to clinical-scale manufacturing.