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WHITE PAPERS AND CASE STUDIES

• Biomarker Selection And Measurement In Neurodegenerative Trials

  Biomarkers are crucial for early diagnosis of neurodegenerative diseases. Learn about key protein biomarkers through an exploration of clinicopathologic correlations and measurement strategies.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Disinfection For Purified Water Loop For Kamada Pharmaceuticals, Israel

  An Atlantium HOD™ (Hydro-Optic Disinfection) UV system was installed at the outlet of a PW tank to serve as the primary disinfection barrier, with water circulating through the system at 6m³/hr before reaching the points of use.

• Collaborative Variability Reduction In Cell Culture Media

  Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

• Progressing A Cystic Fibrosis Treatment With A Strong Culture Match

  Collaborate with an experienced CMO that combines transparency, expertise, and a shared commitment to help advance complex biologics from preclinical research to clinical success.

• X-Ray Inspection For Supplement Safety

  Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

• Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

  Discover how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s innovative microbubble technology.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

• Next Generation Sequencing In Viral Safety Testing

  Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

• Hot Water Disinfection For International Hotel Chain, Israel

  See how an Israeli hotel chain slashed energy costs by 27% while ensuring Legionella compliance through innovative UV water disinfection technology.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• Advancements In Microbial Manufacturing Of Biopharmaceuticals

  Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.