Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique.
- Complaints Into Practical Action: Human Factors Drug Delivery
- Human Factors: A Key Factor In Regulatory Approvals
- Regulatory Attention To Human Factors: How Much Is There?
- Gaining An Edge In GLP-1 Production
- Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
- Where Drug Delivery Falls Short And What The Industry Should Do Next
- BCS Class IV: Rescuing Hard To Deliver Molecules With Nanoformulation
- Patient-Centric Drug Delivery: Do Possible And Preferable Always Align?
ON-DEMAND WEBINARS
Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.
Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.
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.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1487365113-scientist-with-gloves-tablet-in-hands-microscope-lab]( "Realizing The Promise Of New Approach Methodologies (NAMs)")
Realizing The Promise Of New Approach Methodologies (NAMs)NAMs are transforming risk assessment. Learn how integrating advanced in vitro models and computational tools can improve efficiency, reduce costs, and strengthen regulatory decision-making.
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![West-Vials Glamour V9]( "Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations")
Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal CombinationsThe study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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![iStock-843765314-scientist-lab]( "Solutions For Accelerated Pharmaceutical Development")
Solutions For Accelerated Pharmaceutical DevelopmentExplore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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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-1346739457-environmental-sustainability-pill-tablet-capsule-OSD-green]( "Reducing Environmental Impact At All Stages Of The Medicine Journey")
Reducing Environmental Impact At All Stages Of The Medicine JourneyExplore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.
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![GettyImages-946264472-test-tube-lab]( "Selecting Container Closure Components: A Data-Driven Approach To CCI")
Selecting Container Closure Components: A Data-Driven Approach To CCIDiscover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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![Pharm Manufacturing Facility GettyImages-1087218874]( "Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs")
Accelerate Development Of Enabled Formulations For Poorly Soluble DrugsExplore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.
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![GettyImages-1365580848-ubiquinol-softgel]( "Seven Softgel Myths: Are You Missing Your Softgel Opportunity?")
Seven Softgel Myths: Are You Missing Your Softgel Opportunity?Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?
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![iStock-1205850790-oral-solid-dose-OSD-tablet-capsule-pill]( "Understanding Of Amorphous Solid Dispersions & Their Downstream Development")
Understanding Of Amorphous Solid Dispersions & Their Downstream DevelopmentUnderstanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
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![Biologics: When Glass Vials Fail At Low Temperatures, Consider A Cyclic Olefin Polymer System]( "When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System")
When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer SystemIf the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.
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]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
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.
