Featured Articles
ADVANCED DELIVERY DEVICES - New Drug Delivery & Stabilization Platforms Gaining Global Interest
Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 1 – Introduction)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD; believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
MARKET BRIEF - Latin America Next-Generation Biosimilars Market: Opportunities & Future Growth
Lucila Rocca, Healthcare Industry Analyst, Frost & Sullivan, indicates the Latin American Biosimilars market will grow at a significant rate in the next 5 years, and the importance of establishing rigorous regulation will stimulate this market growth.
MANAGEMENT INSIGHT - In Pursuit of Ethics: Reflections On Why We Do What We Do
In January, the FDA banned imports from a fourth Ranbaxy plant in India after an unscheduled inspection revealed a lab littered with flies, a leaking…
RESIDUAL IMPURITIES - Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
LYOPHILIZATION PACKAGING - Packaging Freeze-Dried Substances - There Are Options
Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.
PREFILLABLE SYRINGE TECHNOLOGY - BD Neopak - Delivering the Next Generation in Glass Prefillable Syringes
Justin M. Wright, PhD, and Herve Soukiassian highlight significant development and commercial manufacturing investments in glass PFS container technology for the biotech industry with three key areas of focus: reducing overall variability, reducing SbVPs, and increasing glass strength and durability performance.
BUSINESS DEVELOPMENT - Product Versus Service Business
John A. Bermingham discusses running a service business for the first time after having led products businesses his entire career, and quickly begins to see the differences.
DATA MANAGEMENT - Taking Regulated Content to the Cloud
Martin Magazzolo believes the cloud presents a strong alternative to costly internal solutions when managing content for R&D, allowing companies to shift their focus to innovation.
ROUNDTABLE DISCUSSION: Reformulating Opioids to Deter Abuse
Contributor Cindy H. Dubin talks with some leading Specialty Pharma companies to find out how they are formulating technologies to deter the growing problem of opioid abuse.
EXECUTIVE INTERVIEW - EMD Millipore: Enhancing the Bioavailability of Active Pharmaceutical Ingredients
Drug Development Executive: Steffen Denzinger, Head of Portfolio Development at EMD Millipore, talks about bioavailability challenges and how EMD Millipore’s formulation portfolio and expertise are helping the pharmaceutical industry achieve maximum efficacy with APIs.
ADVANCED DELIVERY DEVICES - Engineering the Perfect Click for Drug Delivery Devices
Chris Hurlstone says device developers – whether human factors experts or industrial designers, mechanical engineers, or risk analysis teams – know engineering of the click is critical, yet this aspect of device design, like many others, is frequently not given the attention it deserves.
BIOAVAILABILITY ENHANCEMENT - A New Year for Solubility Enhancement
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW - Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering
Drug Development Executive: Amy Heintz, PhD, Senior Research Scientist at Battelle, speaks about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions.
MANAGEMENT INSIGHT - Six Reasons Why the Affordable Care Act May Be a Bad-Tasting Medicine That Could Heal Our Industry
Derek Hennecke says that whether you love the Affordable Care Act (ACA) or abhor it, the fact is, there are billions of dollars of government money in play and some industries are going to benefit tremendously.
EXECUTIVE INTERVIEW - Aptar Pharma: From Self-Injection to Auto-Injection
Pierre Carlotti, Vice-President of Marketing and Communication for Aptar Pharma Prescription Division, talks about the market for auto-injectors and some relevant market trends, and explains how his company went about designing and developing a novel auto-injector.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part III of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., concludes his multiple-part series discussing today’s most challenging issues in solubility.
API INTEGRATION - Modification of Silicone Chemistry & Its Influence on Release Rates of APIs
Brian Reilly and Nathan Wolfe say integrating APIs into a silicone system requires consideration of multiple factors, such as compatibility of the silicone with the API and, more generally, achievement of the prescribed dose delivery rate over the prescribed amount of time. And because different APIs can potentially alter the properties of silicone and vice versa, modification of silicone chemistry may be necessary.
MARKET BRIEF - The Market for Type 2 Diabetes Therapeutics - Key Findings From a Recent Analysis of Global Drug Development Efforts
Debbie Toscano, Senior Industry Analyst, Frost & Sullivan, summarizes key findings of Frost & Sullivan’s recent analysis of the type 2 diabetes therapeutics market, which examines in detail the insulin and non-insulin segments of this market on a global level.
EXECUTIVE INTERVIEW - Catalent Applied Drug Delivery Institute: Helping to Get Better Drugs to Waiting Patients, Encouraging the Adoption of Advanced Delivery Technologies
Drug Development Executive: Kurt Nielsen, PhD, CTO & SVP, Innovation & Growth, and Founding Institute Board Member, discusses the Institute, its goals, structure, and activities.
