INFUSION DRUG DELIVERY ARTICLES
Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
Biosimilar success depends on seamless execution. Strong care coordination, patient education, and operational readiness are essential to improve access, adherence, and outcomes.
INFUSION DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden asks panelist John Higgins to describe early-stage molecule selection and formulation considerations for determining drugability for biologics. Higgins introduces the guiding importance of the Target Product Profile (TPP).
Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.
How are EDDOs (Essential Drug Delivery Outputs) related to Design Controls during the design and development of a combination product? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how the concept of Design Outputs fits within the broader context of Design Controls.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, underscores the importance of cascading business and regulatory strategies for advanced therapies and delivery products throughout the organization’s quality management systems.
INFUSION DRUG DELIVERY RESOURCES
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![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Considerations In Formulation Development Of Injectable Solutions")
Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
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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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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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![GettyImages-1264101698-lab-research-scientist]( "Formulation Development From Preclinical To First-In-Human")
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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![BD-libertas]( "Wearable Injectors: An Alternative To Traditional Intravenous Administration")
See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
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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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![GettyImages-1393951695-IV-bag-intravenous]( "Bag Flling Is Now Possible In The United States")
Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).
INFUSION DRUG DELIVERY SOLUTIONS
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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.
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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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![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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![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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![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-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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![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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![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.
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