DRY-POWDER THERAPEUTICS – Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler

Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.

FORMULATION FORUM – Understanding of Amorphous Solid Dispersions & Their Downstream Development

 Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.

INHALATION DELIVERY – Inhaled Drug Development: Optimizing Delivery

Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.

BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

OPEN INNOVATION PLATFORM – Incentivizing Drug Delivery Research Using an Open Sharing Platform

Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.




Disposable Aseptic Isolation System

In this Whitepaper, Solo Containment (now part of ILC Dover) walks you through their process, from concept-to-development, for creating a fully disposable Grade-A aseptic fill/finish isolation system.


ProPerma™ Oral Formulation Technology

ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…