ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Safely Navigating The Transition From MDD To MDR

  If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

• Comparing Vial Container Closure Systems

  Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.

• 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.

• A Robust Extractables Data Package Helps Drive Patient Safety

  Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

• 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.

• The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation

  The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.

• A Risk-Based Approach To Injectable Combination Product Development

  Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

• Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations

  The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

• Wet Milling Vs. Dry Milling In The Pharmaceutical Industry

  Read about the considerations necessary for choosing between wet milling and dry milling for a specific active pharmaceutical ingredient.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.