INFUSION DRUG DELIVERY ARTICLES

Laboratory-Mouse-GettyImages-172267826 New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development

The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase. 

INFUSION DRUG DELIVERY VIDEOS

"One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, mid-size, and large-scale batches.

In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Dominik Witzigmann of LNP (lipid nanoparticle) platform developer NanoVation Therapeutics about addressing a wide range of patient needs while partnering with biopharma and navigating the regulatory landscape to do so.

What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

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

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.