Several companies are in Phase 3 development of intratumoral drug products, all with a lead product in a cancer other than melanoma, based on novel chemistry.
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
- Rethinking Drug Delivery To Combat Antibiotic Resistance
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Overcoming Melt Processing Challenges
Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.
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Maximize Global Regulatory Collaboration
When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.
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De-Risking The Transition From Vial To Drug-Device Combination Product
When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.
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A Solvent-Free, Fusion-Based ASD Manufacturing Process
Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.
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Patient-Centric Formulations In Pediatric Adherence
Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers and support safer, more effective therapies for children across developmental stages.
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The Gateway Delivery To The Brain
Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
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Age-Appropriate Pediatric Formulation Development
There is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
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Mitigating Particulate Risk In Injectables
What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?
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Getting Ahead Of PFAS Risk In Pharmaceutical Manufacturing
Pharma can’t simply eliminate essential PFAS uses. A phased, risk-based strategy can address footprint, exposure, and supply risks amid regulatory uncertainty.
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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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Container Closure Systems For Biosimilars: Is There Regulatory Difference?
In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
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.

