INFUSION DRUG DELIVERY VIDEOS

In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.

What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.

A significant challenge in gene therapy delivery – particularly for in vivo approaches – has been limitations in cargo capacity of the gene payload carrier. In this episode of Supplier Horizons, host Tom von Gunden talks with technical director Gabe Meister and scientist Tony Duong from biopharmaceutical research and development company Battelle about the promise of polymer nanoparticles as delivery vehicles for treating rare diseases with in vivo gene therapies.

What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies underscores the criticality of management commitment to and engagement in the process.

INFUSION DRUG DELIVERY RESOURCES

INFUSION DRUG DELIVERY SOLUTIONS

  • 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.

  • 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.

  • B. Braun manufactures a wide variety of interventional product solutions for a multitude of medical applications and procedures. Products can be made available as stand-alone solutions or incorporated into a sterile private-labeled device or kit.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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