Articles, App Notes, Case Studies, & White Papers

1. Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products 10/16/2024

   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.

2. Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing. 1/12/2026

   By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.

3. Starting The IV: Why Autonomous Cannulation Could Be The Next Step In Critical Care 5/13/2026

   As care shifts beyond hospitals, IV access is a bottleneck. Autonomous cannulation could ease labor shortages while improving speed, consistency, and access to IV therapy across settings.

4. Evaluation And Identification Of Subvisible Particulate Matter In Injections

   Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.

5. Microphysiological Systems: Closing The Gap Between Models And Medicine 9/2/2025

   Microphysiological systems (MPS) use human cells to model tissue function, offering faster, more predictive insights for drug discovery, safety testing, and personalized medicine—bridging gaps left by animal and 2D models.

6. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

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

7. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

   Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

8. Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon 9/18/2024

   Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.

9. Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement 6/8/2022

   Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

10. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.