SPECIAL FEATURE - Excipients: Strategic Enablers of Innovation
Ahead of CPHI, Cindy H. Dubin learns from leading excipient suppliers how multi-functional and organic excipients are impacting novel formulations and how AI is becoming a valuable tool in formulation development.
SPECIAL REPORT - Excited About Excipients?
Kurt R. Sedo and Cindy H. Dubin take a deep dive into the excipient market, highlighting how new excipients enable advanced drug products and how AI and computation tools are helping match excipients to APIs.
FORMULATION FORUM - Oral Delivery of Nanocrystal Suspensions
Dr. Shaukat Ali and Dr. Jim Huang shed light on the challenges and opportunities to improve solubility and enhance oral bioavailability of molecules in nanocrystals or crystalline suspensions.
DRUG DELIVERY - Powder to Patient: Advancing Reconstitutable Injectables Through Integrated Aseptic Powder Filling & Next-Generation Dual Chamber Delivery
Laxman Halleppanavar and David Phasey offer a focused perspective on connecting formulation, particle engineering, aseptic manufacturing, device design, and patient use within one scalable development pathway.
SILICONE CHEMISTRY - Modification of Silicone Chemistry & Its Influence on Release Rates of APIs
Matthew Kihara explains how silicone lends itself to optimization, customization, and therapeutic performance, and that modifying silicone chemistry presents an opportunity to optimize drug release behavior and system performance.
VACCINE TECHNOLOGY - Delivering Better Global Vaccination Programs by Removing the Needle, Syringe & Fridge
Robin Cohen says that novel vaccine technology does not relate simply to the antigen, but also to method of administration and route of delivery, stressing that removing needle, syringe, and refrigerator are a step toward better vaccination programs.
EXECUTIVE INTERVIEW - Lonza: From Formulation to Scale-Up: Advancing Dry Powder Inhalation for Biologics
Dr. Kim Shepard and Dr. Beatriz Fernandes talk about the evolving respiratory delivery landscape, the technologies shaping the field, and development strategies for addressing formulation while initiating risk mitigation.
CONTROLLED RELEASE - Alginate Beads for Oral Drug Delivery: Formulation Strategies for Controlled Release & Enhanced Bioavailability
Vardan Ter-Antonyan, Casey Kikendall, and John Davis review the formulation principles governing calcium alginate bead performance and discuss the relationship between bead structure and controlled release.
ARTIFICIAL INTELLIGENCE - AI Has Transformed the Pharmacovigilence Landscape
Raj More surveys the field of AI tools and looks at some emerging trends as well as factors that will influence the development of these platforms.
EXECUTIVE INTERVIEW - Bone Biologics Corp.: Recombinant Protein Development in Engineering Active Orthobiologics & Targeted Bone Therapies
Jeffrey Frelick describes how Bone Biologics’ lead proprietary recombinant human protein is addressing the challenge of balancing strong bone growth with patient safety.
LIFE SCIENCE PERSPECTIVE - A Validated Modality Changes the Equation
Kelly Page shares her personal perspective on taking therapeutic modalities across the finish line and how she applies what she learns into future programs to turn scientific progress into improved patient outcomes.
SPECIAL FEATURE - Injection Devices: Advancements Converge to Expand Patient Possibilities
Cindy H. Dubin speaks with injection device developers about creating devices that are intelligent, intuitive, patient-centric systems that make advanced therapies easier, safer, and more accessible to use at home.
ARTIFICIAL INTELLIGENCE - AI/ML Supporting Biomarker & Target Discovery
William Whitford explains how Artificial Intelligence/Machine Learning provide new capabilities in analyzing the rapidly increasing type and amount of biological data employed in identifying potential biomarker and disease targets.
EXECUTIVE INTERVIEW - Portal Instruments: Beyond Springs – Portal Prime Nexus™ Autoinjector is a Versatile Solution for Biologics
As biologics become larger, more viscous, and more complex, software offers a fundamentally better way to control and optimize delivery.
PLATFORM TECHNOLOGY - How a Novel Immunotherapy Platform is Unlocking the Cancer-Fighting Potential of Unconventional T Cells
Michal Sheleg, PhD, shines a spotlight on the promise of MAIT cells to fight cancer by turning to an untapped source: human placentas.
FORMULATION FORUM - High Concentration Biologics for Injectable Drug Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, discuss how the development of high- and ultra-high-concentration biologics aims to enable smaller-volume, patient-friendly subcutaneous injections.
BIOPHARMA MARKET LAUNCH - De-risking Global Market Entry Through Redundant Capacity & Flexible Manufacturing
John Ward and Paul Hamill stress that launch readiness matters as much as development progress. Thus global expansion is shifting to a near-term priority and CDMOs can reduce the risk of a global launch through agile downstream execution.
DELIVERY SYSTEM DEVELOPMENT - Supporting Earlier Delivery-System Decisions in Injectable Drug Development Through a USP <382>-Aligned System-Level Approach
Sarah Masucci and Crystal Salvans highlight a shift from evaluating individual syringe components independently toward system-level qualification of the complete PFS container-closure system, with the goal of simplifying development and supporting product quality and regulatory expectations.
LYOPHILIZATION - Great Expectations: Selecting & Managing CDMO Partnerships for Lyophilized Injectables from Development Through Commercialization
Carrie A. Schults outlines considerations of managing these partnerships with an emphasis on proactive risk management to control timelines and cost.
QUALITY MANAGEMENT SYSTEM - One QMS, Four Delivery Platforms: Can Your Quality System Manage Complexity at Scale?
Melanie Cerullo emphasizes that when quality systems manage rather than react to complexity, faster development and safer more effective medicines ensue.
