Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
- From Exosomes To Nanodrugs: Advancing Therapeutic Delivery For CNS Repair
- Risk Is the Spine: What The First 100 QMSR Inspections Reveal
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- The Hidden Operational Complexities Of Home Infusion
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- Surgical Therapeutic Design: Key Considerations In Formulation And Delivery
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- When Software Becomes Part Of The Medicine
ON-DEMAND WEBINARS
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
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.
Discover how these groundbreaking Oral GLP-1 Analogs therapies are reshaping obesity management and addressing key challenges in formulation and delivery.
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1426603202-scientist-research-lab]( "Application Of A Novel Temperature Shift Process For Particle Engineering")
Application Of A Novel Temperature Shift Process For Particle EngineeringSpray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.
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![GettyImages-1370115311 outsourcing]( "Contract Design And Development Vs. In-House: Finding The Best Fit")
Contract Design And Development Vs. In-House: Finding The Best FitOutsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.
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![GettyImages-1219894348-lab-cleanroom-PPE]( "Driving Sustainability In Spray Drying Through Enabling Technologies")
Driving Sustainability In Spray Drying Through Enabling TechnologiesBy transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.
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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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![Artificial Intelligence, Technology, Robot, Futuristic, Data Science, Data Analytics, AI-GettyImages-1480912336]( "AI: The New Partner In Medical Device Development")
AI: The New Partner In Medical Device DevelopmentInvolving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL")
How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mLA customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
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![GettyImages-2086161977-blister-packaging-liquid-medical-medicine]( "The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions")
The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric SolutionsPharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.
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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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![sterile-injection-capsules]( "Collaborating With A CMO To Bring Your Sterile Injectable Product To Market")
Collaborating With A CMO To Bring Your Sterile Injectable Product To MarketReview considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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![Injection Vials GettyImages-125930642]( "The Importance Of Understanding Materials In Medical Product Development")
The Importance Of Understanding Materials In Medical Product DevelopmentExplore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.
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.
