Featured Articles
PARTICULATE IDENTIFICATION – Particle Identification for Improvement of Pharmaceutical Production
Kathryn A. Lee, PhD; Markus Lankers, PhD; and Oliver Valet, PhD, discuss various aspects with regard to microscopic particle counting, sizing, and identification using Raman, laser-induced breakdown, and IR spectroscopies, and how these techniques can help accurately identify particles.
THERAPEUTIC FOCUS – Ischemic Stroke: Treatment Beyond the First 3 Hours
Rick Pauls, MBA, says treatment of ischemic strokes hinges on getting tPA into the patient within just few hours of the stroke occurring, but getting to the hospital quickly requires a great deal of luck, and anything that buys the patient more time is worth pursuing.
EXECUTIVE INTERVIEW – ALCAMI: Delivering Solutions by Connecting at Every Level
Dr. Stephan Kutzer, CEO, President, and Chairman of Alcami, discusses his company’s business strategy, outsourcing trends, how the company meets the growing needs of customers, and why companies choose Alcami.
EXTERNAL DELIVERY – International Business, Something to Consider
Not every product, technology, or service is intended for international trade. But then again, not every business is intended to stay at home either. So…
INDUSTRY PERSPECTIVES – What Surprised You the Most This Past Year?: Your Colleague’s Perspectives
The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past year. We thought it would be intriguing to hear what some of your colleagues said surprised them most.
COMBINATION CORNER – Keys to a Robust Combination Product Design Verification & Validation
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
DELIVERY PLATFORM – Encochleated Drug Formulations: Enhancing Efficacy, Minimizing Toxicity
Roelof Rongen, MBA, MS, indicates drugs for serious fungal and microbial infections currently require IV administration at doses associated with significant toxicity. Orally administered, encochleated formulations of a broad-spectrum of fungicidal and anti-microbial medications may provide delivery of anti-infective drugs at therapeutic levels while minimizing drug-associated side effects.
SPECIAL FEATURE – Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
CARBON NANOTUBES – MGMR™ – A Medical-Grade Carbon Nanotube Designed for Medical Applications
Joseph S. Dillon, PhD, MBA, and Lainie Mulvanny discuss the transformation of CNTs into a unique composition of matter, marking a complete departure from the dirty, tangled micron bundles of CNTs that frustrated medical researchers for years.
PROTEIN CRYSTALS – Reshaping Traditional Biotherapeutic Formulations
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
EXCLUSIVE ONLINE CONTENT
2019 Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS – Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.