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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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.
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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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Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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Making The Right Choice For Multiparticulate Modified Release Dosage Forms
Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release dosage forms. Understand if it's the right method for your modified-release project.
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Why It Is Never Too Early To Consider Tungsten Interactions
A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.
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Considerations In Formulation Development Of Injectable Solutions
Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
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Enabling Subcutaneous Delivery For Improved Patient Compliance
The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.
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A Pathway For Regulatory Success For Devices In Combination Products
Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.
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Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon
Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.
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.

