INFUSION DRUG DELIVERY ARTICLES

25_DDL_Regulatory_Reconnaissance_logo_color GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products

In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

INFUSION DRUG DELIVERY VIDEOS

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 front-of-mind regulatory movements of note. From her role as Director of Regulatory Policy at Novo Nordisk, Rumi Young identifies the inclusion of combination products in FDA initiatives focused on combatting chronic diseases and improving patient accessibility. Panelists Barr Weiner and Fran DeGrazio weigh in.

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, traces the evolution of delivery technologies for the opioid overdose drug Naloxone to illustrate enablers of emergency use not requiring trained professionals to administer.

In this episode of In Combination, the technical leadership team from device consultancy Suttons Creek joins host Tom von Gunden to discuss trends in the patient landscape driving innovation in drug delivery, including combination products and therapies. The conversation covers patient self-administration, emerging modalities, and key considerations in product development, regulatory pathways, and the supply chain.

In this episode of Sit and Deliver, host Tom von Gunden talks with Merck VP of Pharmaceutical Sciences and Clinical Supply Allen Templeton about formulation and device considerations for combination products and other delivery systems deployed across a range of molecule types and sizes. The conversation takes them from small molecules, through peptides and mAbs, to large molecule biologics, across various routes of administration including oral, injectable, and inhalation.

INFUSION DRUG DELIVERY RESOURCES

INFUSION DRUG DELIVERY SOLUTIONS

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.