ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Four Special Fill/Finish Considerations For Vaccine Production

  Examine considerations regarding the handling and process for fill/finish to ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost.

• 5 Novel Techniques For Solubility Enhancement

  Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.

• Biodegradable Polymers For Parenteral Drug Delivery

  Long-acting, complex drug delivery products, particularly those based on injectable microparticles, nanoparticles, and implants, are among the most attractive parenteral products.

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  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery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

• Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages

  Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

• Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

  The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

• The Largest LOE Event In US Pharma History

  Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

• Expanding Home-Based Care With A Next-Gen On-Body Delivery System

  As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

• Navigating Regulatory Challenges In Oligonucleotide Therapeutics

  Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.