We caught up with Davinder Ramsingh, MD, to talk about the potential of using low-intensity focused ultrasound (LIFU) to open the blood–brain barrier.
- 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- Unpacking The FDA Draft Guidance On Container Closure Systems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
- Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics
- Inquiries In Inhalation, Part 2: Having A Nose For Innovation
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients
Dysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how microencapsulation enabled formulation of a water-soluble powder drives patient adherence.
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Rational Design & Development Of Lipid- Filled Hard Capsules
With the increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development.
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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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Application Of A Novel Temperature Shift Process For Particle Engineering
Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.
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Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process
Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.
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Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems
Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
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Four Challenges That Stall Advanced Therapy Development
Many challenges can stall an advanced therapy’s development, and the vast majority of them are tied to inadequate preclinical planning and partner vetting. Find how to foster a better development strategy.
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Reliable Components For The Lifecycle Of Your Injectable Drug Product
As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
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2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance
Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.
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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.
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.

