Featured Articles
PLATFORM TECHNOLOGY - The 3DNA® Platform for Targeted Drug Delivery
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
EXTERNAL DELIVERY - P.U.M.P. IT UP
John A. Bermingham, asks if you have ever been really hungry? He doesn’t mean the hunger you experience in the morning or just before dinner. He’s talking about major league hunger!
COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
PACKAGING SYSTEMS - Container Closure Integrity in Cryogenic Storage Environments
Eugene T. Polini, MBA, reviews how cryogenics has proven to be especially useful in the pharmaceutical industry, where cryogenic storage is being utilized to ensure the efficacy of advanced therapeutics, such as biologics and stem cell therapies.
DEVICE STUDY - The Intuitiveness, Ergonomics & Usability of the Credence Companion® Safety Syringe: A Formative Study
John A. Merhige, MEM, and Lisa Caparra, RN, present an informative human factors study to evaluate and assess the intuitiveness, ergonomics, and usability of the Credence Companion® Staked Safety Syringe.
EXECUTIVE INTERVIEW - Catalent: Increasing Efficiency & Flexibility for the Clinical Supply Chain
Wetteny Joseph, President of Clinical Supply Services at Catalent Pharma Solutions, discusses the changing nature of clinical trials and the supply of materials for studies, and how Catalent is investing in new solutions, systems, and facilities to assist the biopharmaceutical industry.
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%?
ADVANCED DELIVERY DEVICES - Sophisticated Connected Wearables: Boosting Biologics’ Compliance, Value & Patient Satisfaction
Michael D. Hooven, MSME, says the new, most advanced wearable large-volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance, and cost.
SPECIAL FEATURE - Platform Technologies: Not Just for Big Pharma
Contributor Cindy H. Dubin recently spoke with several companies that are debunking the theory that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating innovative platforms.
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.
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.
