INHALATION DRUG DELIVERY ARTICLES
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 RESOURCES
-
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
-
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
-
Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
-
Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
-
Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
-
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
-
Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
INHALATION DRUG DELIVERY SOLUTIONS
-
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.
-
Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.
-
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.
-
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
-
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).
-
Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
-
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
-
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.
-
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.