INJECTABLE DRUG DELIVERY ARTICLES
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
-
![GettyImages-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Imaging Large Volume Subcutaneous Injections To Inform Clinical Design")
New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.
-
![GettyImages-1185624320-scientist-lab-smiling]( "Redefining Patient-Centric Drug Delivery")
Preloaded on-body delivery systems reduce user error risks during treatment, while patient preference data supports simpler, more reliable home administration.
-
![02 West]( "Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics")
All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
-
![West_CZ Insert Needle 115860aw 11569_RGB_2]( "Designing Robust Studies To Meet Auto-Injector Performance Requirements")
Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.
-
![04 West]( "Fixtures And Surrogates For Combination Product Performance Testing")
The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.
-
![Vaccine injectable vials and syringe GettyImages-1252804942]( "Packaging And Containment: Get Your Products To Market Faster")
Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
-
![West-MDO 2 - GC_APP_Photoshoot 2021 Single Vials Glamour V8]( "How Recent Trends Impact Bringing Your Molecule To Market")
With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![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.
-
![ASEPTiCell ScreenShot 1]( "Robotic Multi-Format Filling & Closing System")
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
-
![DD 1 - GCAPP_Valor size 2 Vial]( "The Future Of Glass Packaging Is Here")
Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
-
![BD]( "Easy-To-Use 1 mL Disposable Autoinjector")
BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
-
![BD-xtraflow-]( "Glass Prefillable Syringe Solution Delivering Complex Biologics")
BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
-
![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
-
![denesting]( "Pharmaceutical De-Nesting Equipment For Syringes And Cartridges")
The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
-
![iStock-1057830102-gloves-lab-sample]( "Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials")
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.
-
![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.
-
![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
