In this article, Fran DeGrazio discusses the opportunities, challenges, and benefits for biopharmaceutical product developers in transitioning from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment.
- Can We Cure Diabetes?
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
- Red Blood Cell-Based Delivery: Promising Steps Forward
- Stability And Release Testing For Delivery Devices: Waived Or Wanted?
- Microneedles In Drug Delivery: From Bench To Patch
- How Targeted Nanoparticles And Circular RNA Are Advancing CAR-T Development
- Beyond The Surface: Balancing Efficacy, Safety, And Patient Experience In Ophthalmic Delivery
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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Snapshot Of The Parenteral Drug Delivery Market
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
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Comparing Vial Container Closure Systems
Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.
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Best Practices For Ensuring Quality In Biologic Products
New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes.
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Monoclonal Vs Polyclonal Antibody Production- Explained Step By Step
Selecting the optimal antibody framework is critical. Discover how monoclonal and polyclonal epitope specificity impacts manufacturing complexity, batch uniformity, and long-term therapeutic efficacy.
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An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals
Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.
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Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing
This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
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Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells
Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.
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2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance
Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.
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Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization
Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.

