We caught up with Minutia CEO Katy Digovich to discuss engineered iPSC-derived islets intended for transplantation into the forearm, which could make a functional cure for insulin-dependent diabetes broadly accessible.
- Red Blood Cell-Based Delivery: Promising Steps Forward
- Stability And Release Testing For Delivery Devices: Waived Or Wanted?
- Microneedles In Drug Delivery: From Bench To Patch
- How Targeted Nanoparticles And Circular RNA Are Advancing CAR-T Development
- Beyond The Surface: Balancing Efficacy, Safety, And Patient Experience In Ophthalmic Delivery
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- Biomaterials In Ophthalmology Are Reshaping Ocular Drug Delivery
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
ON-DEMAND WEBINARS
Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
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.
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine")
The Paradigm Shift: From Scale-Up To Scale-Out In Genetic MedicineThe shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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![Syringes GettyImages-171324030]( "Engineering Advances In Needle Geometry To Accommodate Viscous Biologics")
Engineering Advances In Needle Geometry To Accommodate Viscous BiologicsExplore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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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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![West-MDO 1 - GC_APP_Assembled and Unassembled Vials V1]( "FAQs On The Revised EU GMP Annex 1: Volume 1")
FAQs On The Revised EU GMP Annex 1: Volume 1The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.
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![GettyImages-1327620750-lab-research]( "The Role Of Micronization In The Journey To Drug Product Development")
The Role Of Micronization In The Journey To Drug Product DevelopmentMicronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
10 Ways To Align Your Medical Device With Human Factors Industry Best PracticesDiscover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![GettyImages-1002000796-lab-research-scientist-development]( "Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives")
Closing The Duration Gap In FDA-Approved Long-Acting ContraceptivesA gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.
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![05 West]( "Leachables Method Development, Validation And Relevant ICH References")
Leachables Method Development, Validation And Relevant ICH ReferencesIt is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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![iStock-1127257350-innovation-ideas-lightbulb]( "Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway")
Innovative Formulation Technologies By 505(b)(2) Regulatory PathwayRevitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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![RA-Device-V6-March-16_copy]( "Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization")
Insights Into Drug Delivery Device Manufacturing From Development Through CommercializationBiologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
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]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
Procuring Packaging And Delivery Systems: Single Versus Dual SourcingIn this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
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.
