Featured Articles
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.
EXTERNAL DELIVERY – The Big Hack Attack
John A. Bermingham says it is not a matter of IF your business is going to be hacked but WHEN your business is going to be hacked, but the vast majority of businesses in the US do not have any plans in place for such an event.
MANAGEMENT INSIGHT - The Wisdom of Bees: What the Honeybee Can Teach You & Your Company About Making Better Decisions
Derek Hennecke says once we understand what happens in our brains as we weigh our options, we can extrapolate this knowledge and look with fresh eyes at how CDMOs, large pharma, and the industry make decisions.
COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
PULMONARY DELIVERY - Pulmonary Delivery of Insulin to Treat Diabetes - A Debacle
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
EXECUTIVE INTERVIEW - Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
LYOPHILIZATION - A Lyophilization Scale-Up Model: Lessons Learned & Best Practices
Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.
EXTERNAL DELIVERY - Lead Your Company, Don’t Over Manage It
For many years, I have witnessed a continuing discussion on the question of, “what’s the difference between leadership and management?” Or is there one? I…
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
IMMUNOTHERAPY RESEARCH - The Shift Toward Combination Therapies
Jean Pierre Wery, PhD, indicates immunotherapy in combination with traditional treatments has the potential for becoming a more effective alternative to the current standard of care. These types of combination therapies are currently under investigation and appear to have synergistic effects compared to the use of one therapy alone.
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
DRUG DELIVERY - PLEX(TM) Local Drug Delivery Platform Enables Prolonged, Controlled-Release Medications
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
