Once dominated by IV infusions administered in hospital settings, the biologics industry is now at a crossroads. Here's why the future of biologics delivery is high-concentration subcutaneous injectables.
- Smart Drug Delivery Systems: Emerging Market Trends
- Oral Therapies Take Center Stage For PsO And PsA Treatment
- Design Controls For Drug Delivery Devices, Part 1: A Process Primer
- The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization
- The Technologies Propelling GLP-1 Analogues
- Are CDMO Partnerships The Answer To Manufacturing Capacity Issues?
- Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3
- Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials
ON-DEMAND WEBINARS
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.
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.
Explore 3D screen printing’s potential to revolutionize pharmaceutical manufacturing with scalable, customizable, multi-drug tablets and precise, patient-centric drug release profiles.
Various animal models — including non-human primates, rabbits, minipigs, and canines — present benefits and limitations for preclinical studies. Explore the insights to optimize the path to clinical trials.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-843765314-scientist-lab]( "Solutions For Accelerated Pharmaceutical Development")
Solutions For Accelerated Pharmaceutical DevelopmentExplore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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![GettyImages-1306440102-sterile-injectable-syringe]( "The Growth Of Sterile Injectables")
The Growth Of Sterile InjectablesLearn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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![GettyImages-1694119644-Insulin_Injector_Pen]( "Delivering On GLP-1 Demand: Combining Device And Supply Strategy")
Delivering On GLP-1 Demand: Combining Device And Supply StrategyMeeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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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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![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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![GettyImages-1371993517-syringe-vial-mask-vaccine-inject]( "Meeting The Growing Demand For Pre-Filled Syringes")
Meeting The Growing Demand For Pre-Filled SyringesThe market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.
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![Scientist in lab GettyImages-872025342]( "Harness High-Quality PBPK Modeling To Enhance Clinical Readiness")
Harness High-Quality PBPK Modeling To Enhance Clinical ReadinessPhysiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.
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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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![Keys To Driving Consistent Quality In Contract Manufacturing]( "Keys To Driving Consistent Quality In Contract Manufacturing")
Keys To Driving Consistent Quality In Contract ManufacturingComplex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
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![GettyImages-1253545551-OSD-pill-tablet-oral-solid-dose]( "A Custom Pill For Every Patient")
A Custom Pill For Every PatientBy enabling the creation of personalized medications and offering a wider range of products, 3D printing technology has the potential to enhance patient care and improve the healthcare experience.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
In her monthly column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "Design Controls For Drug Delivery Devices, Part 1: A Process Primer")
In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls.
- Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges
- Use-Related Risk Analysis: Considering The FDA Guidance On URRA
- Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond
- 5 Top-Of-Mind Drug Delivery Topics In 2024
- Understanding Essential Drug Delivery Outputs: Things To Know About EDDOs
- 5 Keys to Supplier/Purchasing Controls – And Product Quality
- Preparing For The FDA QMSR: Will You Be Ready?
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
- Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
