INFUSION DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INFUSION DRUG DELIVERY VIDEOS
In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on post-market regulatory considerations and processes for combination products. Among the topics covered are post-approval changes, design outputs, patient safety, and various regulatory guidances.
INFUSION DRUG DELIVERY RESOURCES
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![combination]( "Combination Products: Market Trends And Regulatory Considerations")
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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![Singota-DSC03221]( "Developmental Testing Of IV Solutions")
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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![Cleanroom Scientists Using Tablet GettyImages-1341292153]( "High-Throughput Platform Propels Gene Editing Therapy Research")
Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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![GettyImages-1069859094-IV-bag-intravenous]( "Mitigating Hidden Risks: Extractables And Leachables")
Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.
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![Computational Science: Disruption In Biopharma Discovery]( "Formulation Research Strategy For Discovery- Stage New Drug Candidates")
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Snapshot Of The Parenteral Drug Delivery Market")
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
INFUSION DRUG DELIVERY SOLUTIONS
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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.
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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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![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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![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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![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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![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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![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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![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.
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