INFUSION DRUG DELIVERY ARTICLES

In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls.
INFUSION DRUG DELIVERY RESOURCES
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The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.
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Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.
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Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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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.
INFUSION DRUG DELIVERY SOLUTIONS
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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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August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
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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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B. Braun OEM Division is experienced in designing and manufacturing standard and custom valves ranging from small to large scale volumes. These valve products are available as stand-alone components, or may be incorporated into sterile, private-label kits and assemblies.
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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.
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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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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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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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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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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.
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