ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Keys To Driving Consistent Quality In Contract Manufacturing

  Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.

• Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

  The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

• Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

  Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

• 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.

• Increasing Bioavailability With Amorphous Solid Dosage Formulations

  Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

• 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.

• Driving Sustainability In Spray Drying Through Enabling Technologies

  By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

• A Pathway For Regulatory Success For Devices In Combination Products

  Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

• 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.