issues
September 2026
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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.
FEATURES
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.
REGULATORY COMPLIANCE - Navigating ISO 23908:2024 & EN ISO 23908:2025 Harmonization: What It Means for Your Combination Product Strategy
Murtaza Rana and Aurélie Rebuffet reflect on how a revised standard is an opportunity to reassess how sharps injury risks are addressed across product development, regulatory submissions, and lifecycle management
25 Years of Trust, Partnership & Progress
To Our Readers, Advertising Partners, and Industry Colleagues, When Drug Development & Delivery began in 2001, the pharmaceutical and life sciences landscape looked very different than it does today. Over..
