Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition.
- Unpacking The FDA Draft Guidance On Container Closure Systems
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics
- Inquiries In Inhalation, Part 2: Having A Nose For Innovation
- Inquiries In Inhalation, Part 1: The Breadth Of Breath
- PLGA: A Workhorse Polymer Behind Modern Depot Long-Acting Injectables
- Designing Nanoparticles: Why Size Comes First
- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
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.
-
A Custom Pill For Every Patient
By enabling the creation of personalized medications and offering a wider range of products, 3D printing technology has the potential to enhance patient care and improve the healthcare experience.
-
How MedTech And Pharma Are Responding To Rising R&D Pressures
MedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk and cost. These distinct paths are reshaping product development.
-
Contract Design And Development Vs. In-House: Finding The Best Fit
Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.
-
Rational Design And Development Of Long-Acting Injectable Dosage Forms
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
-
Impact Of Post-Covid Literacy Decline On Medical Device Studies In Youth
Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data.
-
Strategies For Accelerating The Development Of Modified Release Oral Forms
Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
-
Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device
Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.
-
Applying Automation To The Manufacture Of Drug Delivery Devices
Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.
-
Design And Packaging Advantages For Cell And Gene Therapy Drugs
With the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
-
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.

