In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.
Discover how aligning packaging strategy with technology transfer requirements can accelerate timelines, control costs, and support successful injectable drug product manufacturing.
Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![inject-GettyImages-2283670652]( "What's Next For NAMs? Moving From Barriers To Breakthroughs")
What's Next For NAMs? Moving From Barriers To BreakthroughsThe future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.
-
![GettyImages-2151620900 antibody, IgG]( "CMO As Partners For ADC Process Development, Scale-Up, Optimization")
CMO As Partners For ADC Process Development, Scale-Up, OptimizationADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.
-
![iStock-827581062-lab-computer]( "An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals")
An Elegant Solution For Delivery Of Acid Sensitive PharmaceuticalsSustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.
-
![Doctor-patient-GettyImages-1345513639]( "Evolution Of Novel Polymers To Overcome Limits In Sustained Drug Delivery")
Evolution Of Novel Polymers To Overcome Limits In Sustained Drug DeliveryDegradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes and polyester amides. Explore a brief history of the development of PEA polymers.
-
![GettyImages-1248237924 IV]( "Starting The IV: Why Autonomous Cannulation Could Be The Next Step In Critical Care")
Starting The IV: Why Autonomous Cannulation Could Be The Next Step In Critical CareAs care shifts beyond hospitals, IV access is a bottleneck. Autonomous cannulation could ease labor shortages while improving speed, consistency, and access to IV therapy across settings.
-
![Delivered _by _DeGrazio_Logo_Color_2]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
Procuring Packaging And Delivery Systems: Single Versus Dual SourcingIn 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.
-
![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
-
![West]( "Design And Packaging Advantages For Cell And Gene Therapy Drugs")
Design And Packaging Advantages For Cell And Gene Therapy DrugsWith the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.
-
![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Engineering Approaches To Respiratory Drug DeliveryExplore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
-
![GettyImages-1288978528 Scientist Using Microscope In Lab]( "A New Framework For Identifying Nitrosamine Risks And Derisking Products")
A New Framework For Identifying Nitrosamine Risks And Derisking ProductsExamine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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
-
![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.
