In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
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- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Device Design For Usability And Risk Reduction
Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.
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Key Considerations When Filling Dual Chamber Syringes
Dual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.
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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.
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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.
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Delivering On GLP-1 Demand: Combining Device And Supply Strategy
Meeting 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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Sustainability Considerations For Drug Delivery Device End-To-End Solutions
Learn how to address the gradual unlinking of economic activity from the consumption of finite resources and the removal of waste to support and help prevent a global climate catastrophe.
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High Potent Formulation Development In Oncology
Examine the vital role formulation development plays in oncology outsourcing and how sponsors can increase their chances of success with the right CDMO partner.
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Leveraging Integration At Each Phase Of A Drug Delivery System Project
By 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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Flying On Two Wings: Balancing Local Agility And Global Quality In China
As China expands its role in drug development, injectable therapy programs face new demands. Learn how manufacturers are scaling quality, devices, and production for global success.
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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.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

