In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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).
- Inquiries In Inhalation, Part 2: Having A Nose For Innovation
- Inquiries In Inhalation, Part 1: The Breadth Of Breath
- PLGA: A Workhorse Polymer Behind Modern Depot Long-Acting Injectables
- Designing Nanoparticles: Why Size Comes First
- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
- From Vial To Prefilled Syringe: Mastering The Development Transition
- Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics
- Can We Cure Diabetes?
ON-DEMAND WEBINARS
Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.
Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1219894348-lab-cleanroom-PPE]( "Prioritize Safety And Mitigate Risk In HPAPI Manufacturing")
Prioritize Safety And Mitigate Risk In HPAPI ManufacturingAs highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.
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![GettyImages-950086574-oral-solid-OSD-pill-tablet-capsule-development]( "Strategies For Accelerating The Development Of Modified Release Oral Forms")
Strategies For Accelerating The Development Of Modified Release Oral FormsCareful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
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![West-BIO 1 - 88_NovaPureSyringes_0922]( "A Pathway For Regulatory Success For Devices In Combination Products")
A Pathway For Regulatory Success For Devices In Combination ProductsReady 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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![BO 2 - GC_App_^CZ vial with stopper and seal stack up]( "Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization")
Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To CommercializationWhile in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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![GettyImages-1337453095-doctor-patient]( "Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System")
Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery SystemWhether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.
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![GettyImages-1178834429-implant-chip-research-delivery]( "Implantable Drug Delivery: Are We There Yet?")
Implantable Drug Delivery: Are We There Yet?Implantable drug delivery offers precise, localized treatment, yet biological barriers and market complexities remain. Explore the factors determining if these systems are ready for broad adoption.
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![GettyImages-1253545551-OSD-pill-tablet-oral-solid-dose]( "A Custom Pill For Every Patient")
A Custom Pill For Every PatientBy enabling the creation of personalized medications and offering a wider range of products, 3D printing technology has the potential to enhance patient care and improve the healthcare experience.
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![GettyImages-1300035668-nanoparticle-particle]( "Exploring Lipid Nanoparticles For Drug Delivery")
Exploring Lipid Nanoparticles For Drug DeliveryUsing lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.
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![iStock-1268181219-glass-vial-packaging-sterile]( "Container Closure Integrity: A Risk-Based Approach")
Container Closure Integrity: A Risk-Based ApproachContainer closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Contract Design And Development Vs. In-House: How To Find The Best FitExplore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Unpacking The FDA Draft Guidance On Container Closure Systems")
Unpacking The FDA Draft Guidance On Container Closure SystemsIn 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.
