ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

  The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

• An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals

  Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

• Improve Speed To Market By Mitigating Vial And Stopper Incompatibility

  These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

• Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

  Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.

• Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control

  In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.

• Crystallization Process Dev: Ramping Up Bench-Scale Control

  Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

• The Dynamic Regulatory Environment Of Drug-Device Combination Products

  Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Responding To Trends In Prefilled Delivery: Component Assessment And Selection

  Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

• The Growth Of Sterile Injectables

  Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.