ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Is Your Combination Product Drug-Led Or Device-Led?

  The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

• 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.

• PFAS In Medical Devices: Expert Insights On Frequently Asked Questions

  Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.

• 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.

• Navigating Regulatory Challenges In Oligonucleotide Therapeutics

  Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

• Reliable Components For The Lifecycle Of Your Injectable Drug Product

  As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

• Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1

  Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

• The Role Of Micronization In The Journey To Drug Product Development

  Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.

• 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.

• Integrated Strategies for Achieving Regulatory Milestones Faster

  Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.