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- Unpacking The FDA Draft Guidance On Container Closure Systems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
ON-DEMAND WEBINARS
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Doctor Preparing Injection Site GettyImages-1379313214]( "Enabling Subcutaneous Delivery For Improved Patient Compliance")
Enabling Subcutaneous Delivery For Improved Patient ComplianceThe ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.
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![GettyImages-1441662840-lab-team-communication-collaboration]( "4 Most Common Reasons For Medical Device Material Failures")
4 Most Common Reasons For Medical Device Material FailuresMaterial failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.
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![respiratory]( "Trends In Combination Products")
Trends In Combination ProductsAs demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine")
The Paradigm Shift: From Scale-Up To Scale-Out In Genetic MedicineThe shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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![GettyImages-136640925-vial-vaccine]( "Zero-Stress Low Volume Aseptic Filling For Solids And Liquids")
Zero-Stress Low Volume Aseptic Filling For Solids And LiquidsAseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.
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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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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Advancing A LNP Formulation To Clinical And Commercial Manufacturing")
Advancing A LNP Formulation To Clinical And Commercial ManufacturingLipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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![GettyImages-1425605790 Life Sciences Training. Scientists Using A Computer In A Lab]( "The Role Of Psychological Principles In Med Device Training Design")
The Role Of Psychological Principles In Med Device Training DesignExplore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.
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![GettyImages-1371707479-lab-mask-team-partnership]( "Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products")
Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug ProductsDrug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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![Adare-2]( "Layer By Layer: 3D Screen Printing And The Future Of Drug Development")
Layer By Layer: 3D Screen Printing And The Future Of Drug Development3D screen printing can produce tablets across a range of release profiles, from conventional immediate release tablets to multi-compartment drug delivery systems that mix different release profiles.
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.
