INFUSION DRUG DELIVERY ARTICLES
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
INFUSION DRUG DELIVERY VIDEOS
Both uFMEA (Use Failure Mode Effects Analysis) and URRA (Use-Related Risk Analysis) tools are available during combination product development for conducting risk assessments related to human factors. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss scenarios in which a uFMEA might be used to inform a URRA regulatory submission.
In this episode of Supplier Horizons, host Tom von Gunden discusses with Chief Scientific Officer Ying Tam from LNP platform developer Acuitas Therapeutics the use of lipid nanoparticles as RNA delivery vehicles across an expanding range of targetable indications, including outside the liver. Among the advances discussed are delivering CAR-T therapies in vivo, loading personalized therapeutic payloads into preformed vesicles, and maintaining RNA stability throughout targeted cellular delivery.
In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden asks panelist Dominick DeGrazio about considerations around the alignment of a biologics formulation with a delivery device. In commenting on deviceability, DeGrazio points to key determiners such as the Target Product Profile (TPP), preferred dosage form, and existing platform technologies versus new device landscaping.
In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden relays an audience question about increased FDA regulatory scrutiny around human factors. Panelists Jonathan Amaya-Hodes and Shannon Hoste comment on the importance of clinical data in regulatory submissions and in approval pathways.
INFUSION DRUG DELIVERY RESOURCES
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![GettyImages-1270488644-infusion-patient-nurse-doctor-IV-intravenous]( "Advancing Drug Delivery At Home: Auto IV Cannulation")
Autonomous IV therapy extends care beyond clinics, using imaging, precision control, and adaptive intelligence to improve vein access and enable safe treatment in more settings.
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Accelerating Gene Therapy With HITSCAN Platform")
Battelle’s HIT SCAN™ platform accelerates gene therapy by rapidly designing, screening, and optimizing nanoparticle drug delivery systems using high-throughput robotics and machine learning.
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![GettyImages-1393951695-IV-bag-intravenous]( "Bag Flling Is Now Possible In The United States")
Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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![Nanoform]( "Small Is Powerful And Sustained")
Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
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![Telehealth virtual ipad elderly]( "Hospital To Home: What It Means For Patients, Providers And Medical Devices")
Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.
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![BD-libertas]( "Wearable Injectors: An Alternative To Traditional Intravenous Administration")
See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
INFUSION DRUG DELIVERY SOLUTIONS
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![GettyImages-1392016982 business meeting]( "Medical Device Technical Due Diligence")
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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![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.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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![iStock-1241630232-IV-drip-intravenous]( "IV Solution Expansion")
In recent years, hospitals, clinics, and others have experienced chronic shortages of medical solutions. The Solutions for Life initiative is a billion-dollar investment in meeting nationwide demand for these products.
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![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.
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![RASR]( "Filling System For Pharmaceutical IV Bags: RASR")
RASR filling and closing machines are designed to treat IV bags. These machines are able to fill single chamber as well as dialysis multi-chambers bags.
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![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.
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![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.
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![GettyImages-1069859094-IV-bag-intravenous]( "Excel IV: An Evolving Market Affirms The Value Of An Established Offering")
These containers can be delivered with a full line of solutions used in clinical settings, including basic saline, heparin premix, and lidocaine. The chemistry used to produce the container uses neither polyvinyl chloride (PVC) nor the plasticizer DEHP.
INFUSION DRUG DELIVERY NEWS
- Melbourne-Developed Drug Delivery Platform Delivers 'Impressive' Results In International Bowel And Ovarian Cancer Trial
- Race Executes Agreement With Ardena For GMP Manufacturing Of RC220
- Acasti Announces WuXi Clinical As CRO To Conduct STRIVE-ON Pivotal Phase 3 Safety Trial For GTX-104 In aSAH Patients
- Ascendia Pharmaceuticals Develops Novel Nanoemulsion IV Formulation For Clopidogrel That Received IND Approval
- Viridian Therapeutics Announces Partnership With Drug Delivery Innovator Enable Injections
- Scaling Up Capacity, Eitan Medical Opens New Manufacturing Facility Bolstered by Semi-Automated Production Lines