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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
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![Stevanato]( "Overcoming A Failed Design Verification Test For Your Delivery Device")
If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.
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![GettyImages-1285108730-syringe-self-injection-treatment]( "Self-Injection Of Biologics Made Easy")
Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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![West Pharma - Article 5 - 4040 Graphic]( "Design Success Combined With Expertise In Testing And Raw Material Selection")
Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
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![GettyImages-2235582013-prefilled-syringe-liquid-manufacturing]( "Success Factors For Pre-Filled Syringe CMO Selection")
Within the past few decades, there has been a steady increase in the use of pre-filled syringes (PFS) for parenteral administration of biologics, biosimilars, and other drugs.
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![BO 1 - GCApp_clemex (both machines with person)]( "Is It Ever Too Soon To Start Your Performance Testing Assessment?")
Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
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![MDO 3 - GC_App_SIS_SelfDose_044]( "Unlocking The Potential Of Self-Administered Injectable Medicines")
Explore how patients and health care providers perceive and consider using patient-administered medicines to manage chronic conditions, specifically self-administered injectables and on-body delivery systems.
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![iStock-1045448388-oligonucleotide-PCR]( "Navigating Regulatory Challenges In Oligonucleotide Therapeutics")
Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![BIMI]( "Aseptic Filling System For Pharmaceuticals: BI-MI")
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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![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.
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![West-1]( "Simplify The Journey With A Combination Product Solution")
Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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![GettyImages-1279969622-self-injector-injection]( "The Intersection Of Material Science And Medical Device Design")
Learn how leveraging our expertise in fundamental materials science and applied engineering can help you not only avoid failures but also resolve them swiftly through our Rapid Response process.
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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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![Clinical Excellence – From Molecule To Milestone_Ypsomed]( "Clinical Excellence – From Molecule To Milestone")
Ypsomed accelerates clinical progress by reducing barriers across clinical development, enabling earlier study readiness, greater visibility and more informed decisions.
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![chemistry-tech-center-GettyImages-1417397137]( "Battelle's Chemistry Technical Center (CTC)")
Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
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![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.
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![BD Medical]( "Passive Needle Guard For Pre-Filled ISO Standard Glass Syringes")
The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.
