Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
- What Patients Actually Want From Connected Drug Delivery
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?
- A Practical Framework For Selecting Long-Acting Injectable Platforms Across Therapeutic, Product, And Delivery Constraints
- Using Low-Intensity Focused Ultrasound To Open The Blood–Brain Barrier
- Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
- Oral Combination Therapies: Navigating Development Complexities
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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Ophthalmic Drug Delivery: Meeting Modern Challenges With A Next Generation Solution
Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.
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Steps To Overcome Challenges Associated With Biologic Formulation Development
Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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4 Factors Affecting Solubility Of Drugs
Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.
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Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products
Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
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Functional Performance Of Stoppers To Support Multipuncture Use
Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.
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Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery
Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.
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Sample Sizes For Performance Testing Of Combination Products, Packaging
When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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Considerations In Design And Development Of Novel Combination Drug-Delivery Devices
Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.
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Vial Adapter Transfer Device Compatibility With Cell Therapies
Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.

