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
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
Discover how an integrated ADC strategy addresses containment, analytics, fill-finish, and inspection challenges to improve product protection, process reliability, and delivery performance.
What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.
Establishing unified component standards through collaborative innovation eliminates unnecessary investment, reduces development timelines, and ensures scalable, patient-centered delivery systems.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![addiction_aid_bottle_3560541]( "Maximize Global Regulatory Collaboration")
Maximize Global Regulatory CollaborationWhen marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "Safe Syringe Solutions For Lipid Nanoparticles")
Safe Syringe Solutions For Lipid NanoparticlesPrefilled syringes improve lipid nanoparticle dosing accuracy and administration. Advanced containment solutions with cross-linked coatings preserve stability and accelerate development timelines.
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![GettyImages-1353123922-doctor-patient]( "Taste Masking 101: Optimize Taste And Improve Patient Outcomes")
Taste Masking 101: Optimize Taste And Improve Patient OutcomesTaste masking is integral for a drug product’s final formulation. It can serve to increase patient acceptability and adherence to a therapy, in turn bolstering regulatory acceptance and commercial potential.
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![Compliance GettyImages-1212446127]( "Compliance Considerations For Emergency-Use Delivery Systems")
Compliance Considerations For Emergency-Use Delivery SystemsBecause auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.
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![GettyImages-1448043410 3D printing]( "3D Screen Printing: Enabling A New Generation Of Complex Formulations")
3D Screen Printing: Enabling A New Generation Of Complex FormulationsScreen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.
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![GettyImages-1309471798 respiratory]( "Outlining The Trends And Challenges In The Inhaled Drug Delivery Market")
Outlining The Trends And Challenges In The Inhaled Drug Delivery MarketExplore the latest trends and solutions in inhaled drug delivery, with a focus on overcoming dry powder formulation challenges to advance next-generation therapeutics.
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![West Pharma - Article 5 - 4040 Graphic]( "Design Success Combined With Expertise In Testing And Raw Material Selection")
Design Success Combined With Expertise In Testing And Raw Material SelectionLearn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
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![GettyImages-1214112149-lab-team-collaboration-research]( "Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying")
Less Mess, Less Stress, Best Expressed: An Alternative To Spray DryingAlthough well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.
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![Scientists Mixing Solution In Lab GettyImages-1443286944]( "Formulation Development For Injectables")
Formulation Development For InjectablesA uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.
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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
Is Your Combination Product Drug-Led Or Device-Led?The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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.
