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- Unpacking The FDA Draft Guidance On Container Closure Systems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
See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.
Ensuring medication adherence in pediatric patients presents challenges for pharmacotherapy. Explore various dosing solutions and learn how to streamline your pediatric development journey.
Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
Watch to hear Steven Facer, Adare's Vice President of Business Development EU/ROW, discuss the challenges of pediatric oral solid dose manufacturing and how to overcome them.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Safeguarding Cell Therapy Cryopreservation: Primary ContainersReview different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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![BD Medical - Libertas Feature]( "Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics")
Innovation For Subcutaneous Delivery Of Large-Volume Complex BiologicsExplore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.
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![GettyImages-2215842261-lab-scientist-looking-down-research]( "How MedTech And Pharma Are Responding To Rising R&D Pressures")
How MedTech And Pharma Are Responding To Rising R&D PressuresMedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk and cost. These distinct paths are reshaping product development.
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![iStock-1227501239-medicine-tablet-capsule]( "Rational Design & Development Of Lipid- Filled Hard Capsules")
Rational Design & Development Of Lipid- Filled Hard CapsulesWith 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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![Stevanato Group - Autoinjector Assembly Feature]( "How A Flexible Approach To Autoinjector Assembly Can Be Advantageous")
How A Flexible Approach To Autoinjector Assembly Can Be AdvantageousExamine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.
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![Ready-To-Use GLP-1]( "Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs")
Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based DrugsReady-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.
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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Key Considerations For Selecting Flexible FillersFlexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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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-1]( "Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products")
Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination ProductsAs the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.
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.
