Featured Articles
EXECUTIVE INTERVIEW - PYRAMID: Prescription for Building Success Through Partnerships
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.
EXTERNAL DELIVERY - Social Responsibility
John A. Bermingham asks what all the ruckus is about with Mylan, maker of the EpiPen, which raised the cost for a pair of EpiPens over $600, and Turing Pharmaceuticals, maker of toxoplasmosis treatment Daraprim, which raised its price by over 5,000%?
TRAINING DEVICES - Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets
Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.
COMPUTATIONAL METHODS - Formulation Development: An Innovative, Simulation-Based Approach
Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.
SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
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…
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.
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.
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.
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.
THERAPEUTIC FOCUS - Direct Effects™ Cannabinoid Therapy: Medical Cannabis Without Psychoactive & Systemic Effects
Ronald Aung-Din, MD, reports topical CBD is beneficial in treating symptoms of a number of neuropathic and psychiatric conditions. Individual clinical response varied depending on condition treated and on severity and longevity of symptoms, and overall, topical CBD therapy was well tolerated.
RIGHTS MANAGEMENT PROTECTION - You Have the Right to Remain Protected
Tom Johnson says on the surface, rights management protection may look like another expense and another system to maintain, and while that may be true, it is a critical security component that delivers rapid and significant return on investment.
MICROBIAL PRODUCTION - Cutting-Edge inABLE® Technology: The Key to Cost-Effective Production of a Novel Antimicrobial Peptide With Potential for the Treatment of MRSA
Ian Fotheringham, PhD, and Mathew Upton, PhD, report that Infections caused by antibiotic resistant bacteria are an ever-increasing threat to public health, creating an urgent, growing demand for the identification and development of new therapies.
DRUG DEVELOPMENT EXECUTIVE - Crown Bioscience: Enhancing the Drug Development Process
Jean Pierre Wery, President of Crown Bioscience, discusses the requirement for more accurate research models in oncology research, focusing on PDX models that have the ability to more adequately represent the conditions and mechanisms of immunotherapy in human patients.
