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- Unpacking The FDA Draft Guidance On Container Closure Systems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
Learn how evolving ophthalmic regulations, contamination control strategies, and advanced packaging solutions can help support compliance, product quality, and patient safety.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Avoiding The Pitfalls Of LNPs And Complex FormulationsExplore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![BO 1 - GCApp_clemex (both machines with person)]( "Is It Ever Too Soon To Start Your Performance Testing Assessment?")
Is It Ever Too Soon To Start Your Performance Testing Assessment?Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
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![GettyImages-1327624070-lab-research-development]( "Solid Form Screening, Rapid Formulation Selection To Meet Tight Timelines")
Solid Form Screening, Rapid Formulation Selection To Meet Tight TimelinesA comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.
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![GettyImages-824641956 monoclonal antibody]( "Monoclonal Vs Polyclonal Antibody Production- Explained Step By Step")
Monoclonal Vs Polyclonal Antibody Production- Explained Step By StepSelecting the optimal antibody framework is critical. Discover how monoclonal and polyclonal epitope specificity impacts manufacturing complexity, batch uniformity, and long-term therapeutic efficacy.
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![GCAPP_High Class Research Microscope-381_WEST]( "Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product Quality")
Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product QualityStrengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products.
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
Sample Sizes For Performance Testing Of Combination Products, PackagingWhen developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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![GettyImages-1082257488-liquid-capsule-OSD]( "Liquid Capsule Manufacturing: What To Know")
Liquid Capsule Manufacturing: What To KnowCapsules surround a drug in an unflavored, solid barrier enclosure. This article focuses on liquid capsule manufacturing and its advantages.
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![The Importance Of Strategic Alliance Partners In Biopharmaceuticals]( "The Importance Of Strategic Alliance Partners In Biopharmaceuticals")
The Importance Of Strategic Alliance Partners In BiopharmaceuticalsToday’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.
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![Image 3]( "Protecting Your Drug Product: Integrating Engineering And Quality")
Protecting Your Drug Product: Integrating Engineering And QualityEngineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.
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![AST- ASEPTiCell ScreenShot 16]( "The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation")
The Future Of CDMOs: Aseptic Filling Solutions For Growth And InnovationThe rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.
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.
