A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
- Beyond Biologics: A Biophysical Approach To Crohn's Disease
- 6 Packaging And Delivery Challenges For Biologic Therapies
- Does TSLP Inhibition Signal The Next Wave Of Respiratory Biologics?
- Nanosystems And Rare Diseases: Opportunities And Limitations
- 3 Emerging Trends In Drug Delivery Device Pipelines
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Closing The Adherence Gap: The Connected Health Era
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
ON-DEMAND WEBINARS
"One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, mid-size, and large-scale batches.
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.
Discover how to advance new compounds with complex chemistry through each stage of development by refining processes to give fit-for-purpose manufacturability and yields.
Discover an advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1694119644-Insulin_Injector_Pen]( "Delivering On GLP-1 Demand: Combining Device And Supply Strategy")
Delivering On GLP-1 Demand: Combining Device And Supply StrategyMeeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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![Syringes GettyImages-171324030]( "5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes")
5 Ways Pre-Filled Syringes Contribute To Better Patient OutcomesIn our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.
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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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![Oct2020bucket]( "Leveraging Integration At Each Phase Of A Drug Delivery System Project")
Leveraging Integration At Each Phase Of A Drug Delivery System ProjectBy forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.
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![06 West]( "Your Approach To USP <382> For Your Drug Product Packaging")
Your Approach To USP <382> For Your Drug Product PackagingThe USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "Sterile Injectable Therapies: Revolutionizing Lifecycle Management")
Sterile Injectable Therapies: Revolutionizing Lifecycle ManagementThe right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Streamlining The Path To Market For Generic Drug-Device CombinationsDeveloping g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![GettyImages-1306440102-sterile-injectable-syringe]( "The Growth Of Sterile Injectables")
The Growth Of Sterile InjectablesLearn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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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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![West-1]( "Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products")
Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination ProductsAs the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.
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.
