Let's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
- When The Adhesive Becomes The Drug Delivery System
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- 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
ON-DEMAND WEBINARS
See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.
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.
Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.
Spray drying offers a solution to formulation challenges for enhancing the bioavailability of poorly soluble APIs but requires technical capability and operational excellence to accomplish the process successfully.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1413607446-vial-syringe-liquid-scientist-glove]( "Preparing Global Parenteral Sites For Annex 1 Compliance")
Preparing Global Parenteral Sites For Annex 1 ComplianceModern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Autoinjectors: A Revolutionary Leap In Drug Delivery")
Autoinjectors: A Revolutionary Leap In Drug DeliveryExplore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.
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![GettyImages-1311494525 Vaccine Vials]( "2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance")
2R Vials And Deep Cold Storage - Determining Mechanical & CCI PerformanceReview the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.
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![INCOG]( "Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing")
Key Financial Considerations For Phase II Clinical Injectable Drug ManufacturingThis article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
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![GettyImages-1185624320-scientist-lab-smiling]( "Selecting A CDMO For Custom Activated PEGs")
Selecting A CDMO For Custom Activated PEGsCustom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.
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![GettyImages-542939804-lab-device-examiner]( "Harnessing The Power Of New Approach Methodologies")
Harnessing The Power Of New Approach MethodologiesHuman-relevant models are reshaping safety and efficacy decisions, but impact depends on selecting the right tools, integrating evidence, and turning complex data into clear, decision‑ready insights.
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![West1]( "Reliable Components For The Lifecycle Of Your Injectable Drug Product")
Reliable Components For The Lifecycle Of Your Injectable Drug ProductAs drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
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![injectables-syringe-GettyImages-2098817477]( "High-Dose Delivery: Integration And Performance")
High-Dose Delivery: Integration And PerformanceHigh-viscosity therapies bring new delivery challenges. Explore how needle, syringe, and device design affect injection performance, reliability, and user experience.
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![GettyImages-1087218944 Scientists In Sterile Suits Working With Computers In The Laboratory]( "Meet Regulation Requirements With RTU Vials And Cartridges")
Meet Regulation Requirements With RTU Vials And CartridgesSterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.
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![GettyImages-1311641109-capsule-tablet-pill-OSD-oral-solid]( "Capsule Formulation Development: From Dosage Forms To Filling")
Capsule Formulation Development: From Dosage Forms To FillingCapsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.
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.
