Featured Articles
SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity
Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.
BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process
Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.
FUNCTIONAL EXCIPIENTS - Much More Than Filler: Solving the Challenge of Patient Non-Compliance
Carin Siow, PhD, explains how the progress to tackle the root causes of medication mis-use has been frustratingly slow and believes the pharma industry’s secret weapon in the fight against non-compliance are functional excipients.
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
CLINICAL TRIALS - 2023 & Beyond: How Technology is Changing the Face of Clinical Trials
Betsy Wagner and Marie E. Lamont explain how before anyone can take full advantage of this opportunity, education about the technology and the practical benefits, viewed through the lens of understanding historical lessons learned, will be the critical next step.
NATURAL LANGUAGE PROCESSING - Mandatory IDMP Compliance is Almost Here - How NLP Can Help
Simon Johns says with the US scheduled to implement IDMP this year and the EU in the process of implementation, IDMP is no longer just a distant requirement. It is happening now, and all organizations should be prepared for mandatory use this year.
DEVICE DEVELOPMENT - Connected Auto-Injector Development: How to Leverage Human Factors Engineering
Finola Austin examines the human factors process for such devices, including a detailed look at the recent development of the UniSafe® 1 mL auto-injector.
CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success
Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.
SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance
Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.
EXECUTIVE INTERVIEW - Sever Pharma Solutions: Development & Manufacturing of High Potent Polymer-Based Dosage Forms
Tony Listro, Vice President of Technology and Site Lead for SPS’s North American site in Putnam, CT, discusses the company’s recent focus areas as well as current plans for expansion.
SUPPLY CHAIN SOLUTIONS - Steady Supply in Turbulent Times: The Importance of Secure Supply Chains & Drug Packaging Integrity
Peter Belden offers unique insight into strategies that can be applied to weather the turbulent times ahead and ensure a reliable supply of critical drug products to patients, and explores how sustainability and integrity can be attained with the right packaging and supply chain solutions.
THERAPEUTIC FOCUS - Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients With Parkinson’s Disease
Joseph M. Palumbo, MD, says addressing Parkinson’s via the inflammatory pathway offers a unique perspective that was virtually unheard of only 10 years ago.
MEDICAL DEVICE TESTING - Breathing Component Biocompatibility: The Practical Application of ISO 18562
Luminita Moraru, MSc, explains how the medical devices industry has grown and is expanding daily and presents the key steps that need consideration when assessing breathing devices.
EXECUTIVE INTERVIEW - Tarsus Pharmaceuticals: A Journey to Establishing a New Disease Category in Eyecare & Transforming Treatment for Patients With Serious Diseases
Sesha Neervannan, PhD, Chief Operating Officer of Tarsus, discusses the company’s innovative approach to creating a new treatment category for eyelid disease and their strategic focus on advancing other treatments in their pipeline.
2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry
In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.
2023 Respiratory Drug Development eBook – Inhalers Trend Toward Sustainability & Targeted Control
In this fourth annual Respiratory e-book, learn more about Porex and Nemera and their contributions to inhalation drug delivery and device design.
PLATFORM DEVICE - Alina: Shining the “Light” on the Benefits of a Platform Approach to Treating Chronic Conditions
Adam Stops, PhD, says the key to the success of any drug delivery device are factors such as proven technology, low development costs, fast time-to-market, and a strong intellectual property (IP) position for the pharma company, and against this background, platform drug delivery devices have become more important than ever.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First
Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.
