issues

October 2014

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COVER

VACCINE TECHNOLOGY – Vaccine Technologies & the Rationale for New Nanoparticle Formulations

Robert S. Becker, PhD, MBA, and Mark A. Mitchnick, MD, explain how SATx technology provides a new flexible formulation platform for the generation of nanoparticulate vaccine formulations without the limitations of previous formulation technologies that have inhibited the optimization of vaccine potencies and safety profiles.

FEATURES

PREFILLED SYRINGE STERILIZATION – NO2 Sterilization: A Flexible Solution for Prefilled Syringes

Evan Goulet, PhD, and Elizabeth Robbins report on the Noxilizer RTS 360 Industrial NO2 Sterilizer that provides surface sterilization of prefilled syringes with a range of material compatibility and low levels of residuals using its rapid, room-temperature process.

VACCINE TECHNOLOGY – Vaccine Technologies & the Rationale for New Nanoparticle Formulations

Robert S. Becker, PhD, MBA, and Mark A. Mitchnick, MD, explain how SATx technology provides a new flexible formulation platform for the generation of nanoparticulate vaccine formulations without the limitations of previous formulation technologies that have inhibited the optimization of vaccine potencies and safety profiles.

FORMULATION DEVELOPMENT – Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements

Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.

QUALITY-BY-DESIGN – Quality-by-Design: The Good, The Bad, The Inevitable

Michael Lowenborg believes in essence, QbD can be interpreted as a way to maximize time and cost savings by better understanding the components and processes necessary to optimize a drug product’s safety, efficacy, and quality at every stage in development.

NANOEMULSION FORMULATIONS – Nanoemulsion Formulations for Injection & Oral Administration

Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia's EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.

ADVANCED DELIVERY DEVICES – Getting It Right: The Importance of End-User Research in the Design of a New Drug Delivery System

Chris Evans believes that designing a drug delivery system that will truly resonate with patients requires insight into the unique experiences of those users by conducting research that will drive innovation in the design and development process to create a solution that works in a variety of situations.

MANAGEMENT INSIGHT – CDMOs Take Flight: Business Lessons From the Airline Industry

Derek Hennecke spends a lot of his time on an airplane and takes a moment to reflect on the similarities between the airline business and his own. In his opinion, there is no industry more similar to ours.

EXECUTIVE INTERVIEW – SGS Life Science Services: Getting Medicines to Market Quickly & Safely

Drug Development Executive: Mark Rogers, PhD, Senior Vice President Life Science Services at SGS, talks about his company’s evolutionary development and the trends it is witnessing in the analytical testing market.

EXECUTIVE INTERVIEW – BioSpectra: Trusted & Reliabe Source for Intermediates

Drug Development Executive: Richard Mutchler, President of BioSpectra, discusses the company’s unique ability to provide customers with validated, secure, and traceable intermediates that remain affordable.

BUSINESS DEVELOPMENT – Lead Me, Follow Me, or Get Out of My Way

The original quote, “lead, follow, or get out of the way” is attributed to Thomas Paine. The title of this article is a quote attributed to General George S. Patton...

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