ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Enabling Long Lasting Clinical Outcomes In Coronary Stenting

  Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).

• Overcoming Challenges In Cell And Gene Therapy Containment

  Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

• Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

  Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

• Combining Gene Therapies, Carrier Systems, And Medical Devices

  Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.

• Starting The IV: Why Autonomous Cannulation Could Be The Next Step In Critical Care

  As care shifts beyond hospitals, IV access is a bottleneck. Autonomous cannulation could ease labor shortages while improving speed, consistency, and access to IV therapy across settings.

• Why It Is Never Too Early To Consider Tungsten Interactions

  A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.

• Achieving New Heights By Expanding Services, Talent, And Facilities

  As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

• Implantable Drug Delivery: Are We There Yet?

  Implantable drug delivery offers precise, localized treatment, yet biological barriers and market complexities remain. Explore the factors determining if these systems are ready for broad adoption.

• Achieving EU GMP Annex 1 Compliance For Contamination Control

  Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.