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  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs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.

• The Dynamic Regulatory Environment Of Drug-Device Combination Products

  Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

• Enriching Sterile Fill/Finish Services With A Patient-Centric Approach

  Through early collaboration and advanced aseptic technology, organizations can overcome complex formulation challenges to ensure safe, effective treatments reach patients more efficiently than before.

• Expanding Opportunities For Inhaled Drug Delivery

  Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

• Platform Reduces Product Development Time And Cost By 30%

  Using innovative capsule-filling equipment and processing technology, and mini-tablet and drug-layered beadlet manufacturing, you can have an adaptable, easily modified formulation.

• Establishing A Container Closure System — Engineering For Integrity

  CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

• Vial Adapter Transfer Device Compatibility With Cell Therapies

  Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

• Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

  A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

• Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products

  Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.

• How Dermal Delivery Platforms Are Transforming Tomorrows For Patients

  Skin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.