We discuss how selective albumin binding improved tumor delivery in preclinical studies and what these findings could mean for the future of siRNA-based cancer therapies.
- Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
- Oral Combination Therapies: Navigating Development Complexities
- Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Future Of Cancer Drug Discovery Is Targeted Immune Activation
- Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
- Unpacking The FDA Draft Guidance On Container Closure Systems
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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High-Throughput Platform Propels Gene Editing Therapy Research
Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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USP Draft Chapters On CCS: What You Need To Know
Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.
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MIDBA: A New Regulatory Approach To Clinical Device Bridging
When devices evolve, evidence expectations can shift. Explore a risk-based clinical bridging approach to support regulatory decisions.
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Why Connect An Auto-Injector To A Smartphone?
Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not?
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Solving For The Future Of Drug Delivery
Next-gen therapeutics require equally advanced delivery systems—localized, personalized, and precise—to ensure efficacy, safety, and scalability. Delivery is now a central driver of innovation.
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How DFM Promotes Scalability, Repeatability, And Profitability
Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.
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Formulation Development Strategy For Early Phase Human Studies
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
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Combining Patient Centricity And Commercial Viability In Pediatric Product Development
Medication acceptance and adherence are critical concerns in pediatric populations due to these patients’ rapid anatomical and physiological development.
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The Importance Of Strategic Alliance Partners In Biopharmaceuticals
Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.
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Cartridge Filling: Where Precision, Process Control, And Experience Matter
Cartridge drug delivery demands strict controls to guarantee dose accuracy. Early development and testing eliminate variability, prevent defects, and protect patient safety.
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).
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

