ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

• Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products

  IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.

• 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.

• 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.

• Recent Innovations And Enhancements To Pharmaceutical Spray Drying

  Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

• Robotics And AI In Pharma: Driving The Next Wave Of Innovation

  Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

• What's Next For NAMs? Moving From Barriers To Breakthroughs

  The future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.

• Enabling Long Lasting Clinical Outcomes In Coronary Stenting

  Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).

• Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs

  An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.

• 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.