INJECTABLE DRUG DELIVERY ARTICLES
Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
-
![West Pharma]( "Key Considerations For Packaging Solutions For Cell And Gene Therapies")
Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.
-
![Self injection med device GettyImages-1322057207]( "Overcoming Wet Injection Challenges With Human-Centric Design")
By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
-
![Ozempic Insulin injection pen for diabetics-GettyImages-2112991930]( "Decoding the FDA Guidance on Essential Drug Delivery Outputs")
The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
-
![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Considerations In Formulation Development Of Injectable Solutions")
Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
-
![Compliance GettyImages-1348548209]( "Annex 1 – The Brave New World Of Regulatory Compliance")
The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.
-
![Epigenetic therapies of the future_GettyImages-2203738408]( "Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.")
By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.
-
![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.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![GettyImages-1187680243-biological-indicator-sterilization]( "Sterile Drug Product")
Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
-
![West-Feature-GC_App_PFS Components (2)]( "De-Risk Your Combination Product Development")
Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
-
![West-SBO 2 - GCApp_Instron]( "Freeze Your Device Design With An Integrated, Verified PFA System")
Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.
-
![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.
-
![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.
-
![BD_Physioject_IMG_3332-450x300]( "BD Physioject™ Disposable Autoinjector")
BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.
-
![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.
-
![Lipid Nanoparticles GettyImages-1437855772]( "Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles")
Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
-
![GettyImages-1938951579-automation-filling-bottles-modern-robot-manufacturing]( "Aseptic Fill Finish")
One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
-
![Medical professional filling out paperwork-GettyImages-1132204239]( "Bridgeton – Our World Class Fill Finish Facility")
A scalable aseptic environment for diverse injectables, advanced automation, and Annex 1–aligned processes, supporting smooth transitions from development to commercial supply and long‑term strategy.
