Featured Articles
SCALE-UP & MANUFACTURING - Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE - Improving Bioavailability & Solubility: A Top-Down Versus Bottom-Up Approach
Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.
SPECIAL FEATURE - Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
NASAL DELIVERY - A Promising Route of Drug Delivery to the Brain: Scientific Considerations
Vinayak Pathak, MPharm, MBA, indicates after reviewing clinical experiments published in this area, it is evident that formulation design, altering the physico-chemical properties of the drug, addition of absorption enhancers, and mucoadhesive polymers did result in higher bioavailability of drugs in animal models via the nasal route when compared to parenteral administration of the same drug.
SPECIAL FEATURE - Analytical Testing - Contractors Take on the Challenge of Complex Molecules
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
PARTICLE DESIGN TECHNOLOGY - Technical Guide for Solid Dispersion Development
Nathan Barksdale and Elizabeth Hickman, MBA, say there are many articles on the theory and scientific principles underpinning the benefits of ASD, and introduce the reader to the steps involved in the development and manufacturing of an ASD via the spray drying process.
DEVICE TRAINING - Maximizing Patient Adherence by Minimizing the Forgetting Curve
Chris Evans explains how it is important that pharmaceutical companies and their drug delivery system partners proactively address the forgetting curve by rethinking how patients learn to use self-administration systems.
GENE-EDITING TECHNOLOGY - How CRISPR-Cas9 Technology Will Play a Vital Role in the Future of Human Therapeutics & Drug Discovery
Kevin Holden, PhD, explores how this technology can be utilized in research efforts toward the development of new therapies and how it will play a vital role in the future of biopharma and drug discovery.
ANTIBODY THERAPEUTICS - Teneobio’s Next Generation of Multispecific Antibody Therapeutics
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
PACKAGING - Child-Resistant Features for Container Closure Systems
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
TECHNOLOGY-ENABLED HEALTH - Digitally Connected Health Technologies: Blazing Meaningful Trails in Healthcare
Daniel Spors and Kyle Dolbow, PhD, say the overall digital health market is currently $76 billion, and is estimated to grow at 21%, and this space includes life sciences and medical device companies that are incorporating digital technology into their products and services, such as smart inhalers and remote therapy devices.
EXECUTIVE INTERVIEW - Lonza Pharma & Biotech: Taking on the Next Challenges in Small Molecules
Gordon Bates, Head of Chemical Division at Lonza Pharma & Biotech, shares his perspective about industry needs and how strategic acquisitions are enhancing Lonza’s position as a development and manufacturing partner of choice.
OPHTHALMIC SQUEEZE DISPENSER - Eliminating the Need for Additives in Multidose Preservative-Free Eyecare Formulations
Degenhard Marx, PhD, and Matthias Birkhoff highlight their company’s Ophthalmic Squeeze Dispenser (OSD), a multi-dose dropper that relies solely on mechanical measures to prevent microbial contamination of the bottle content.
GENE & CELL THERAPY - Its Growing Potential to Disrupt Drug Research & Healthcare Delivery
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox?
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
EXECUTIVE INTERVIEW - Particle Sciences: Experts in Development & Manufacturing of Complex Dosage Forms
Dr. Mark Mitchnick, CEO of Particle Sciences and CMO of Lubrizol, discusses the rise of complex drug products, the capabilities needed to develop and manufacture these products, and the company’s expansion in this area.
SPECIAL FEATURE - Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
EXECUTIVE INTERVIEW - BioCare, PharmaCare, MedCare: Datwyler’s New Health Care Offering
Torsten Maschke, CEO of Datwyler Sealing Solutions, speaks about the opportunities and challenges the current healthcare industry poses and how they are met by Datwyler’s strategy and products.
DRUG DEVELOPMENT - To De-Risk Patient Acceptance of Biologic Drugs, Focus Early on Delivery
Jeannie Joughin, PhD, asks what does a pharmaceutical company do when everyone wants more effective new therapies but no one – including third-party payers – wants to pay the price for their development? De-risk the drug development process, in every possible way.
PHARMACEUTICAL PACKAGING - How Advances in Pharmaceutical Packaging Are Better Meeting Patients' Needs
Detlev Haack, PhD, and Martin Koeberle, PhD, says an industry-wide focus on the design of packaging that can protect user-friendly dosage forms, as well as improve patient compliance and fit into modern consumers’ lifestyles, has resulted in a wide range of primary and secondary packaging solutions.
