Precision oncology has transformed who receives treatment and what biology we target. The next frontier is designing where therapeutic activity occurs.
- Crossing The Uncrossable: Skin Biology For The Delivery Of Peptide And Protein Therapeutics
- When The Adhesive Becomes The Drug Delivery System
- 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?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Navigating Large-Volume Subcutaneous Biologic Injections
Large-volume subcutaneous delivery is bringing biologic treatments closer to patients. Learn how advances in dosing and device technology are shaping care.
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De-Risking Visible Particles Through Component Selection
Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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Vial Adapter Considerations For Cell And Gene Therapy Applications
Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.
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How To Address Challenges In Oncology Drug Containment
Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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What's Next For NAMs? Moving From Barriers To Breakthroughs
The future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.
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Engineering Approaches To Respiratory Drug Delivery
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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How To Find The Right Balance In Cell Therapy Manufacturing
The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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Vial Containment Systems Based On Elastomer 4031/45 Gray
Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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What Downstream Deviations Reveal About Upstream Process Maturity
Fill finish deviations can reveal upstream process issues early. Identifying these signals helps reduce variability, improve process control, and strengthen sterile injectable manufacturing.
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A Smarter Strategy For Optimizing Oncology Drug Products
John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.
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.

