INJECTABLE DRUG DELIVERY ARTICLES
FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
-
![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Evaluating A Novel Cyclic Olefin Polymer Container System For Storing AAV")
This study investigates the suitability of a container system composed of the novel COP CZ as an alternative for the ultra-cold storage of therapeutically relevant AAV viral vectors.
-
![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.
-
![GettyImages-155373764-cryopreservation-cold-chain]( "Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells")
Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.
-
![GettyImages-1294339649 drug development, cleanroom]( "How DFM Promotes Scalability, Repeatability, And Profitability")
Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.
-
![vystra liraglutide]( "De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions")
BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.
-
![GettyImages-1371993517-syringe-vial-mask-vaccine-inject]( "Meeting The Growing Demand For Pre-Filled Syringes")
The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.
-
![GettyImages-872019514-dna-gene-teach]( "Container Closure Integrity Evaluation For Cell And Gene Therapies")
With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![BD]( "Enabling The Delivery Of Complex Biologics With Ergonomic Solutions")
The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
-
![Singota-aseptic]( "Aseptic Manufacturing Services")
Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
-
![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.
-
![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.
-
![GettyImages-1368429013-vial]( "Available Fill/Finish Capacity With Exceptional Manufacturing Flexibility")
We can fill a wide range of container sizes and volumes in the clinical and commercial manufacturing of sterile injectables. Explore our capabilities in formulation and scale up, manufacturing, lyophilization, and extractables and leachables.
-
![GettyImages-1346675624-lab-research]( "Committed To Quality, Collaboration, Service And Innovation")
West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.
-
![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.
-
![FillFinish_450x300]( "Fill Finish Solution - Maximize Drug Product Recovery")
Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.
-
![Vaccine injectable vials and syringe GettyImages-1252804942]( "Unlocking The Potential Of Your Sterile Injectable")
Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.
-
![Capture]( "Injection Molding")
Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
