Digital solutions provide a unique opportunity for pharma companies to differentiate themselves from competition — delivering new value to patients along their treatment journey and strengthening the core business.
- 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
- Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges
- Growth And Advancements In Transdermal Drug Delivery
ON-DEMAND WEBINARS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach, with industry experts sharing key considerations when planning for scale-up of a development program.
A case study illustrating how to use PBPK modeling, the developability classification system, and the biopharmaceutics drug distribution classification system to facilitate development of a molecule.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1314459863-OSD-manufacturing-pill-tablet-capsule]( "Partnering For Success In Sustained Drug Delivery Formulations")
Partnering For Success In Sustained Drug Delivery FormulationsWith a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions.
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![Prefilled Syringe GettyImages-1284529278]( "Prioritize Your Finished Goods Experience To Safely Deliver Medicine")
Prioritize Your Finished Goods Experience To Safely Deliver MedicineAs demand forecasts evolve, opt to work with a CDMO that can pivot manufacturing strategies seamlessly while accommodating your end-to-end needs, from drug substance to finished goods.
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![iStock-827580992-lab-research-development]( "Overcoming Limitations To Achieve Uniform Dosing")
Overcoming Limitations To Achieve Uniform DosingAn immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.
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![GettyImages-1346675635-lab-tablet-research-team]( "Partnering With Clinicians To Improve Pediatric Formulation Development")
Partnering With Clinicians To Improve Pediatric Formulation DevelopmentGreater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
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![GettyImages-1178374751-syringe-gloves-vial-doctor]( "Your Approach To USP <382> For Your Drug Product Packaging")
Your Approach To USP <382> For Your Drug Product PackagingThe USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Engineering Approaches To Respiratory Drug DeliveryExplore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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![West]( "Vial Containment Systems For Gene And Cell Therapies")
Vial Containment Systems For Gene And Cell TherapiesCZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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![stevanatogroup_light_obscuration]( "Container Selection For A Highly Sensitive Drug Product: A Success Story")
Container Selection For A Highly Sensitive Drug Product: A Success StoryLearn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.
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![West]( "Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform")
Selecting A Vial Container Closure System With The DeltaCube™ Modeling PlatformUnderstand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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![GettyImages-1297414842-lab-computer]( "4 Factors Affecting Solubility Of Drugs")
4 Factors Affecting Solubility Of DrugsImproper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.
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.
