In 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.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Streamlining Primary Container And Device Selection With Predictive Calculations
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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Steps To Overcome Challenges Associated With Biologic Formulation Development
Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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Key Trends And Developments In Injectable Drug Formulation And Delivery
As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.
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Design Verification Testing Of Combination Products
Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.
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4 Most Common Reasons For Medical Device Material Failures
Material failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.
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Stopper Functionality – Key Considerations
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
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Integrated Strategies for Achieving Regulatory Milestones Faster
Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.
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Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics
Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.
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5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes
In 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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Making A Case For A Fixed Dose Combination Drug Strategy
As 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.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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6 Packaging And Delivery Challenges For Biologic Therapies
In 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.

