ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Role Of Psychological Principles In Med Device Training Design

  Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.

• Nanoformed API: A Superior Alternative To Solid Dispersions

  Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.

• Low Temperature Storage Containment For Vial And Syringe Systems

  With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

• 2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

  Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

• When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

  If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.

• Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

  Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

• 3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

  The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

• Delivering On GLP-1 Demand: Combining Device And Supply Strategy

  Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.

• Taking A Best Practice Approach To Contamination Control 

  Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.