ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Overcoming Wet Injection Challenges With Human-Centric Design

  By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.

• Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

  Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

• Is It Ever Too Soon To Start Your Performance Testing Assessment?

  Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

• 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.

• 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.

• Are Drugs Becoming More Lipophilic Over Time?

  Get a deeper look into how drug lipophilicity has evolved over time, its impact on drug development, and the need for new technology to enable new more complex drugs.

• Prefillable Syringe Plungers: A Solution For Low Temperature Storage

  Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

• Inspection Of Injectable Products For Visible Particulates

  Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

• Container Closure Integrity Evaluation For Cell And Gene Therapies

  With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

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  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery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