INHALATION DRUG DELIVERY ARTICLES

How-To-GettyImages-1315383657 Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

INHALATION DRUG DELIVERY VIDEOS

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.

In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, provides a landscape overview of emerging and advancing therapeutic methodologies. These include antibody-drug conjugates, CRISPR-edited gene therapies, companion diagnostics, complex generics, and AI-enabled biomarker identification. 

What types of products in development may need to be assessed in accordance with the FDA’s 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, Natalie, Abts, head of human factors engineering at Genentech, describes several common scenarios that illustrate when a URRA approach may or may not be needed.

Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • 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.

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

  • 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.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

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

  • August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.

  • OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.

  • 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.

  • 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.

  • Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).