The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?
- A Practical Framework For Selecting Long-Acting Injectable Platforms Across Therapeutic, Product, And Delivery Constraints
- Using Low-Intensity Focused Ultrasound To Open The Blood–Brain Barrier
- Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
- Oral Combination Therapies: Navigating Development Complexities
- Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
ON-DEMAND WEBINARS
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.
Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.
See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![Compliance GettyImages-1348548209]( "Annex 1 – The Brave New World Of Regulatory Compliance")
Annex 1 – The Brave New World Of Regulatory ComplianceThe revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.
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![GettyImages-1333253892-doctor-legal-regulatory]( "The Challenges And Opportunities Of Real-World Evidence: Part I")
The Challenges And Opportunities Of Real-World Evidence: Part IExplore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.
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![Evonik]( "Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement")
Benefits Of Microparticle Technology For Oral Drug Solubility EnhancementSpray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.
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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
Improve Speed To Market By Mitigating Vial And Stopper IncompatibilityThese studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Supporting Complex Manufacturing For Liquid And Lyophilized Drug ProductsAseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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![GettyImages-1346675635-lab-tablet-research-team]( "Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations")
Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination FormulationsDr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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![iStock-843765220-pill-glove]( "Achieve Release Profiles And Select Excipients For Formulation Development")
Achieve Release Profiles And Select Excipients For Formulation DevelopmentThe formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.
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![iStock-1191001266-tablet-pill]( "How Approved Drugs Have Evolved Since The '70s")
How Approved Drugs Have Evolved Since The '70sDrugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.
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![GettyImages-1291031560-lab-research-computer]( "5 Novel Techniques For Solubility Enhancement")
5 Novel Techniques For Solubility EnhancementThanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.
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.
