ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Unlocking New Possibilities For Treating Rare Genetic Diseases

  With over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.

• Developmental Testing Of IV Solutions

  As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

• How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential

  Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• Four Challenges That Stall Advanced Therapy Development

  Many challenges can stall an advanced therapy’s development, and the vast majority of them are tied to inadequate preclinical planning and partner vetting. Find how to foster a better development strategy.

• Advancing Chronic Care Through GLP‑1 Innovation

  GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.

• Crystallization Process Dev: Ramping Up Bench-Scale Control

  Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

• Patient-Centric Formulations In Pediatric Adherence

  Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers and support safer, more effective therapies for children across developmental stages.

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  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery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

• Small Is Powerful And Sustained

  Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.