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- Unpacking The FDA Draft Guidance On Container Closure Systems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
-
Minimizing Particulate Risk: Designing For Control
Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.
-
Outlining The Trends And Challenges In The Inhaled Drug Delivery Market
Explore the latest trends and solutions in inhaled drug delivery, with a focus on overcoming dry powder formulation challenges to advance next-generation therapeutics.
-
Formulation Development For Injectables
A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.
-
Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
-
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.
-
The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions
Pharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.
-
Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies
A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.
-
Which Testing Does An Effective Certificate Of Analysis Include?
Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.
-
Streamline Early-Stage Development To Reach The Clinic Faster
Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.
-
Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1
Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.
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.

