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- Unpacking The FDA Draft Guidance On Container Closure Systems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
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
Explore how PEG selection shapes drug development success by understanding the benefits of expert CDMO partnerships that deliver custom solutions to enhance your small molecule program.
By reducing the size of drug particles, nanoforming offers new opportunities — from increased bioavailability to sustained drug delivery. Discover the potential benefits supported by case studies.
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Artificial Intelligence, Technology, Robot, Futuristic, Data Science, Data Analytics, AI-GettyImages-1480912336]( "AI: The New Partner In Medical Device Development")
AI: The New Partner In Medical Device DevelopmentInvolving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.
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![GettyImages-1325865279-patient-doctor]( "The Importance Of A Human Centered Approach To Product Development")
The Importance Of A Human Centered Approach To Product DevelopmentTo meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
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![Syringes GettyImages-171324030]( "Key Considerations When Filling Dual Chamber Syringes")
Key Considerations When Filling Dual Chamber SyringesDual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.
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![GettyImages-1365580848-ubiquinol-softgel]( "Seven Softgel Myths: Are You Missing Your Softgel Opportunity?")
Seven Softgel Myths: Are You Missing Your Softgel Opportunity?Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?
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![West4]( "FAQs On The Revised EU GMP Annex 1: Volume 6")
FAQs On The Revised EU GMP Annex 1: Volume 6The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.
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![GettyImages-946264472-test-tube-lab]( "Selecting Container Closure Components: A Data-Driven Approach To CCI")
Selecting Container Closure Components: A Data-Driven Approach To CCIDiscover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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![West-PO 3 - GCApp]( "Meeting Annex 1: A Proactive Approach To Regulatory Compliance")
Meeting Annex 1: A Proactive Approach To Regulatory ComplianceIt was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
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![GettyImages-1311494525 Vaccine Vials]( "2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance")
2R Vials And Deep Cold Storage - Determining Mechanical & CCI PerformanceReview 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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![West feature]( "Reducing Lead Time & Optimizing Costs")
Reducing Lead Time & Optimizing CostsExplore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.
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![GettyImages-1178834429-implant-chip-research-delivery]( "Implantable Drug Delivery: Are We There Yet?")
Implantable Drug Delivery: Are We There Yet?Implantable drug delivery offers precise, localized treatment, yet biological barriers and market complexities remain. Explore the factors determining if these systems are ready for broad adoption.
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.
