The skin excludes water-soluble macromolecules from getting through. Delivery science has answered not by defeating the barrier but by dismantling specific mechanisms. Let's take a closer look.
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
- Rethinking Drug Delivery To Combat Antibiotic Resistance
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
ON-DEMAND WEBINARS
Explore the role of solid form services in helping meet accelerated timelines of the drug development lifecycle along with examples of robust workflows for fast and thorough solid form screens.
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![image1]( "The Importance Of An Analytical Testing Strategy")
The Importance Of An Analytical Testing StrategyA proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.
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![GettyImages-1302254900_nasal anatomy]( "White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges")
White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And ChallengesExplore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
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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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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Regulatory Considerations For Excipients Used In Lipid Nanoparticles")
Regulatory Considerations For Excipients Used In Lipid NanoparticlesReview the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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![131]( "Gamification: The Answer To Pharma's Non-Adherence Crisis?")
Gamification: The Answer To Pharma's Non-Adherence Crisis?Digital connectivity is transforming the consumer experience and digital technology can now improve the patient experience too, in ways that were just not possible before.
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![iStock-1045448388-oligonucleotide-PCR]( "Navigating Regulatory Challenges In Oligonucleotide Therapeutics")
Navigating Regulatory Challenges In Oligonucleotide TherapeuticsOligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
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![Solving The Silicone Challenge]( "Solving The Silicone Challenge In Pre-Fillable Syringes")
Solving The Silicone Challenge In Pre-Fillable SyringesDiscover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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![Biologics: When Glass Vials Fail At Low Temperatures, Consider A Cyclic Olefin Polymer System]( "When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System")
When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer SystemIf the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.
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![Vials GettyImages-1316775813]( "Four Special Fill/Finish Considerations For Vaccine Production")
Four Special Fill/Finish Considerations For Vaccine ProductionExamine considerations regarding the handling and process for fill/finish to ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost.
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![Capture]( "Finding The Ideal Balance — Where Risk And Cost Of Quality Meet")
Finding The Ideal Balance — Where Risk And Cost Of Quality MeetIt is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
