For the next-generation cell and gene therapies, we must rethink design and controls, and we must reframe the problem from modality to architecture.
- The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
- Conducting A Medical Device Stability Study: A Practical Guide
- Nanotechnology Drug Delivery: A Market Overview
- Combination: The Drug Delivery Word Of The Year For 2026
- In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
- Electronic Drug Delivery Devices Market: Advancing Smart, Connected Healthcare
- Regulating For Patient Safety And Success With Combination Products
- FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
ON-DEMAND WEBINARS
Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
Learn about key product parameters affecting patient acceptability and therapy adherence and taste masking strategies, including organoleptic and barrier coating approaches and microencapsulation technologies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-941351144-Pharmaceutical_Sterile_Tablet_Production_Equipment]( "Making A Case For A Fixed Dose Combination Drug Strategy")
Making A Case For A Fixed Dose Combination Drug StrategyAs patient-centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of health care.
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![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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![iStock-1045448388-oligonucleotide-PCR]( "Navigating Regulatory Challenges In Oligonucleotide Therapeutics")
Navigating Regulatory Challenges In Oligonucleotide TherapeuticsOligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
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![GettyImages-2223908587-doctor-patient]( "How Devices, Instructions, And Packaging Work Together To Improve Safety")
How Devices, Instructions, And Packaging Work Together To Improve SafetyA medical device's user interface is the entire product system: the device, labeling, packaging, and IFU. These elements are crucial for risk mitigation and must be tested holistically.
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![GettyImages-1148337130 product pathway]( "Using 505(B)(2) To Streamline Approval Of Combination Products")
Using 505(B)(2) To Streamline Approval Of Combination ProductsIn recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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![West1]( "Early Decisions To De-Risk The Transition To Combination Products")
Early Decisions To De-Risk The Transition To Combination ProductsThe injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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![West_CZ Insert Needle 115860aw 11569_RGB_2]( "Designing Robust Studies To Meet Auto-Injector Performance Requirements")
Designing Robust Studies To Meet Auto-Injector Performance RequirementsLearn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.
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![04 West]( "Delivering Market Success For Pharma Partners From Concept To Patient")
Delivering Market Success For Pharma Partners From Concept To PatientThe development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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![Multicolored pills-GettyImages-1370358685]( "Solid Form Strategies For Increasing Oral Bioavailability")
Solid Form Strategies For Increasing Oral BioavailabilityOptimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.
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![iStock-1298328343-pill-tablet-bottle-prescription-OSD-oral]( "Key Offerings To Help Support Your OSD On Its Journey To Market")
Key Offerings To Help Support Your OSD On Its Journey To MarketExamine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.
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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![111Delivered-_by-_DeGrazio_Logo_Color_1]( "4 Opportunities For Advancing Drug Delivery")
4 Opportunities For Advancing Drug DeliveryIn this article, Fran DeGrazio identifies four prime opportunities for drug delivery developers to move the dial of innovation into 2026 and beyond. These avenues for advancement include diagnostics, patient tolerability, microdosing, and analytical methodologies.
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.
