INFUSION DRUG DELIVERY VIDEOS

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, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.

Gene therapies aim to treat the root causes of disease rather than merely the symptoms. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Igor Fisch of NewBiologix, a developer of AAV-based gene therapy platform technologies.

When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or 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 potential differences in the contexts, purposes, and degrees of detail in information presented for review.

INFUSION DRUG DELIVERY RESOURCES

INFUSION DRUG DELIVERY SOLUTIONS

  • 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.

  • 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.

  • 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.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.