ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Viral Vector Based Gene Therapy Drug Products: The Right Primary Container

  Explore the major considerations for an ideal primary container for viral vector-based gene therapy drug products and the existing and new solutions in this space.

• 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.

• Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies

  A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

• Lyophilization Contract Manufacturing Services: What To Know

  Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

• 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.

• Drug Formulation Development: Quick Reference Guide

  This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.

• Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization

  While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

• 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.