Featured Editorial
-
Sorriso's Path To Oral Biologics Dosing Is Through The Gut
6/30/2025
Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.
-
From Matrix To Medicine: New Frontiers In Treating Pulmonary Fibrosis And PH
6/25/2025
Halo Biosciences is building a pipeline based on novel insights into how extracellular matrix dysregulation drives disease. We caught up with its leaders to discuss their approach to drug targeting and early development.
-
Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet
6/19/2025
This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.
-
Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms
6/5/2025
Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.
-
3 Lesser Known Keys To Effective Biopharma Supplier Engagement
6/4/2025
In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services.
-
Connected Drug Delivery Devices: Emerging Market Trends
5/29/2025
Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration tools. New market research shares emerging growth and trends.
-
Tips From A Biomedical Engineer For Medical Device Innovation And Compliance
5/20/2025
Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.
-
Formulation Is Key For Y-mAbs' Self-Assembling Antibody
5/16/2025
The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.
-
The Future Of Biologics Delivery: High-Concentration Subcutaneous Injectables
5/12/2025
Once dominated by IV infusions administered in hospital settings, the biologics industry is now at a crossroads. Here's why the future of biologics delivery is high-concentration subcutaneous injectables.
-
Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective
5/1/2025
In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.