ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• 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.

• A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients

  Dysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how microencapsulation enabled formulation of a water-soluble powder drives patient adherence.

• 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.

• Realizing The Promise Of New Approach Methodologies (NAMs)

  NAMs are transforming risk assessment. Learn how integrating advanced in vitro models and computational tools can improve efficiency, reduce costs, and strengthen regulatory decision-making.

• A Custom Pill For Every Patient

  By enabling the creation of personalized medications and offering a wider range of products, 3D printing technology has the potential to enhance patient care and improve the healthcare experience.

• A Glass Package Designed Specifically for Pharmaceutical Use

  A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.

• 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.

• The Importance Of An Analytical Testing Strategy

  A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

• Opioid Reformulation Filed As A CMC Supplement In Less Than A Year

  Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.