Featured Articles
DRUG DELIVERY - PharmaShell®: Enabling Once-Monthly Therapeutics With Atomic Precision Coatings
Anders Johansson, PhD, Polla Rouf, PhD, and Joel Hellrup, PhD, review an innovative drug delivery system that uses nanometer-thin, inorganic coatings to turn short-acting drugs into long-acting injectables.
INJECTABLE DEVICES - Delivering Tomorrow’s Injectables to Patients Today: Responding to a New Era of Demand With Purpose-Built Capabilities
Tommy Schornak examines how evolving therapeutic modalities, delivery systems, and regulatory expectations are reshaping the fill finish landscape.
PLATFORM TECHNOLOGY - Developing Innovative Solutions to One of the Top Public Health Threats: Antibacterial Resistance
Jennifer Schneider, PhD, believes immunotherapy holds the potential to revolutionize the treatment of “hard to treat,” chronic, and often recalcitrant infections.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advancing Targeted Radiotherapeutics for Rare & Difficult-to-Treat Cancers
Dr. Marc Hedrick, CEO of Plus Therapeutics, discusses the company’s targeted radiotherapeutic platform for central nervous system and solid tumor cancers and why internal radiation therapy offers patients a more advanced drug delivery solution compared to traditional external radiation therapy.
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
CONTAINER SELECTION - Why Container Selection is Key to Overcoming Sterile Fill & Finish Challenges for Next-Gen Biologics
Vincenza Pironti explores the importance of container selection for sterile injectable drug products and outlines key factors to consider to optimize the performance, quality, and efficacy of biologics.
EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients
Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.
CLINICAL TRIALS - Keeping Pace With Shifting Drug Development Paradigms for Multi-Indication Therapies
Simon Bruce, MD, and Jack L. Martin, MD, indicate that as developers increasingly embrace multi-indication development, the success of multi-indication therapies will stem not merely from pipeline adjustments, but also from development strategies designed with multi-indication objectives at their core.
EXECUTIVE INTERVIEW - Intensity Therapeutics: Providing Cancer Patients With Treatments That Work
Lew Bender, Founder and CEO of Intensity Therapeutics, discusses the company’s science, clinical program, the drug development process, and more.
SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
SUBCUTANEOUS INJECTIONS - A New Dimension for an Enhanced Injection Experience
Enrico Barichello and Crystal Salvans explore the impact of market trends, focusing on the technical and clinical challenges associated with delivering large-volume, high-viscosity subcutaneous injections. They also highlight the need for optimized delivery systems that can accommodate these formulations without compromising usability or efficacy, as well as the potential advantages such systems may offer for non-viscous injections.
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
EXECUTIVE INTERVIEW - ALZpath: A Diagnostic Assay Changing the Future of Alzheimer’s Disease
Jacob Hunter, Chief Business Officer, ALZpath, Inc., discusses the development and deployment of the company’s proprietary pTau217 antibody, bridging the gap between detection and treatment to improve patient outcomes globally.
FORMULATION DEVELOPMENT - Innovative Drug Delivery Approaches for GLP-1 Agonists: Enhancing Medication Adherence & Treatment Outcomes
Nasrin Mahmoudi, PharmD, PhD, and Michael Baumann, highlight recent developments in GLP-1 agonist formulations and delivery methods, including advanced injectable formulations, novel oral delivery systems, and topical formulations.
