INJECTABLE DRUG DELIVERY ARTICLES
Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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).
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
-
![Cosmetic_Syringe_Luer copy_WEST]( "Ophthalmic Drug Delivery: Meeting Modern Challenges With A Next Generation Solution")
Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.
-
![West-Vials Glamour V9]( "Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations")
The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
-
![West1]( "Reliable Components For The Lifecycle Of Your Injectable Drug Product")
As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
-
![Contract Manufacturing MI_030]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
-
![Simplify the journey]( "Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs")
Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
-
![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Accelerating Gene Therapy With HITSCAN Platform")
Battelle’s HIT SCAN™ platform accelerates gene therapy by rapidly designing, screening, and optimizing nanoparticle drug delivery systems using high-throughput robotics and machine learning.
-
![GettyImages-1346675538-lab-research-development-test tubes]( "Solubility With Lipid-Based Technologies For Oral & Injectable Formulations")
Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![Medical Research-GettyImages-2162956896]( "Medical Device Solutions Fact Sheet")
Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
-
![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
-
![A-MICRO BI]( "Pharmaceutical Vial Filling Machine With Isolator")
Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
-
![West-C&G 3 - 2mL_10mL_Vials_Tubs]( "Daikyo Crystal Zenith® Ready-To-Use Nested Vials")
West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
-
![GettyImages-875547540-Auto_Injector_Parenteral]( "Commercial Autoinjector Capabilities")
Innovative technologies in the pharmaceutical industry are enabling a patient-centric approach in medicine. Auto-injectors provide an easy, convenient drug-delivery system for patient self-administration — improving compliance and dosage accuracy.
-
![leading-cdmo-GettyImages-1417391937]( "A Leading Drug Delivery CDMO")
A look at integrated drug‑delivery expertise, scalable development paths, and advanced manufacturing that speed programs from formulation to global launch while reducing risk and improving efficiency.
-
![BD Neopak™ XtraFlow™ Glass Prefillable Syringe]( "BD Neopak™ XtraFlow™ Glass Prefillable Syringe")
A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
-
![LSC 09.26 Newsletter Ypsomed Fig 1]( "Connected Solutions For Self-Injection")
From enabling connected clinical trials to supporting digital therapy management, our solutions help improve clinical trial operational efficiency and data quality, strengthen commercial success, and empower patients to self-manage their therapy.
-
![iStock-1087219366-fill]( "Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials Of Insoluble Drugs")
Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.
-
![iStock-1214764688-scientist-lab-analyze-research]( "Analytical And Testing Services")
As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
