issues

June 2017

COVER

NEEDLE-FREE INJECTION – Portal PRIME: A Digitally Controlled, Cloud-Integrated Jet Injection System

Patrick Anquetil, PhD, and Gaspar Taroncher-Oldenburg, PhD, report on Portal PRIME, a needle-free and digitally controlled jet injection device that is breaking new ground for injectable drug delivery.

FEATURES

NANOPARTICLES – A Revolution in the Development of Drug Delivery Vehicles

Tim Leaver explains how his company has developed a proprietary technology for the rapid development of nanoparticles and seamless scale-up for clinical studies and commercial production, and how it is transforming the development and manufacturing of a range of nanoparticle formulations from a hit-and-miss affair to a standardized process, accelerating novel nanomedicines from the bench to the clinic.

SPECIAL FEATURE – Wanted: New Excipients to Meet the Demands of a Challenging Industry

Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.

SPRAY-DRIED DISPERSIONS – Particle Engineering of Spray Dried Dispersions: Considerations for Downstream Processing

Aaron Goodwin, PhD, Alyssa Ekdahl, and Deanna Mudie, PhD, demonstrate the tunability of SDD particle properties and the resulting impact on the powder flow and mechanical properties for tablet manufacturability of a given SDD formulation.

CONTRACT MANUFACTURING – Delivering Market Success & ROI to Pharmaceutical Partners

Mike Schaefers, PhD, and Mike Treadaway say more than ever, contract manufacturing must deliver continuous innovation and flexibility to accommodate the delivery of a wide range of drugs throughout each therapy’s lifecycle.

LYOPHILIZATION – Lyophilization Cycle Development: Lessons Learned & Pitfalls to Avoid

John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.

EXECUTIVE INTERVIEW – Pfizer CentreOne: The Value of the Embedded-CMO Model

Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.

MDI CHARACTERIZATION – Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers

David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.

EXTERNAL DELIVERY – Diary of a Wimpy CEO

John A. Bermingham talks about his experiences working for CEOs with great strength and character, as well as those considered to be “wimps” who had very little respect from the management team.

THERAPEUTIC FOCUS – A New Patented Device for Treating Obstructive Sleep Apnea & Snoring

Bob Wieden presents a device he believes addresses the underlying anatomic and physiologic etiology of snoring and OSA in a simple but inventive way, and if developed, has the ability to increase patient compliance by reducing the use of CPAP machines, by making a sufferer's life more comfortable, while preventing many of the contributing diseases.

EXCIPIENT UPDATE – Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating

Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.