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- Unpacking The FDA Draft Guidance On Container Closure Systems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
ON-DEMAND WEBINARS
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
Various animal models — including non-human primates, rabbits, minipigs, and canines — present benefits and limitations for preclinical studies. Explore the insights to optimize the path to clinical trials.
Discover how these groundbreaking Oral GLP-1 Analogs therapies are reshaping obesity management and addressing key challenges in formulation and delivery.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Delivered _by _DeGrazio_Logo_Color_2]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
Procuring Packaging And Delivery Systems: Single Versus Dual SourcingIn this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
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Gaps In Reconstitution Process Filled By Water-For-Injection Syringe
The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.
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![GettyImages-1426603202-scientist-research-lab]( "Application Of A Novel Temperature Shift Process For Particle Engineering")
Application Of A Novel Temperature Shift Process For Particle EngineeringSpray 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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![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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![Image 1]( "Start Packaging Development Early: De-Risk Before You Build")
Start Packaging Development Early: De-Risk Before You BuildWhen packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.
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![Autoinjector-Insulin-Pen-Delivery-Device-GettyImages- 1086688132]( "Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery")
Is The Autoinjector Dead? The Future Of Patient-Centered Drug DeliveryAutoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.
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![Ozempic Insulin injection pen for diabetics-GettyImages-2112991930]( "Decoding the FDA Guidance on Essential Drug Delivery Outputs")
Decoding the FDA Guidance on Essential Drug Delivery OutputsThe FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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![06 West]( "Your Approach To USP <382> For Your Drug Product Packaging")
Your Approach To USP <382> For Your Drug Product PackagingThe USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.
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![GettyImages-1311518492-vaccine-vial]( "A Glass Package Designed Specifically for Pharmaceutical Use")
A Glass Package Designed Specifically for Pharmaceutical UseA comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
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![Scientists Mixing Solution In Lab GettyImages-1443286944]( "Formulation Development For Injectables")
Formulation Development For InjectablesA 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.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Unpacking The FDA Draft Guidance On Container Closure Systems")
Unpacking The FDA Draft Guidance On Container Closure SystemsIn 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.
