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 RESOURCES
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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.
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By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs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.
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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.
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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.
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By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.
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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
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Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
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Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.
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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.
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The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.
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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.
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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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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.
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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.
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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.