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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Engineering Advances In Needle Geometry To Accommodate Viscous Biologics
Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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Achieving EU GMP Annex 1 Compliance For Contamination Control
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
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Rational Design Of Oral Nanosuspensions For Insoluble Drugs
The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.
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Understanding Injectable Drug Container Closure Systems
Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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Approach To Improve Solubility And Bioavailability: Spray Drying
Spray dryers today support the development of some of the most advanced drug formulations, meeting the most precise morphological requirements to ensure performance, stability, and manufacturability.
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Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture
The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."
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Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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De-Risking A Novel Valve Component For Use With Standard Syringe Systems
A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.
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Key Considerations For Emerging Companies When Selecting Packaging Components
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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Addressing Glass Particulates In Injectable Drug Formulations
Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
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.

