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WHITE PAPERS AND CASE STUDIES

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• 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.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• 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.

• Pasteurized Equivalent Water Treatment At Tnuva Ba'Emek, Israel

  In the heart of Israel’s Jezreel Valley, Ba’emek Advanced Technologies—part of the Tnuva Group—faced a critical challenge: how to sustainably reuse water extracted from whey during dairy processing without compromising safety or quality.

• From Problem To Performance: A Custom Filter That Transformed Imaging Quality

  IDEX Health & Science solved a multi-band fluorescence imaging challenge by designing Semrock filters with ultra-deep blocking, steep edges, and wider passbands for exceptional image quality.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

• PV Solutions Optimizing End-To-End Safety In Clinical Development

  Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

• 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.

• Everest Group Life Sciences eCOA Peak Matrix Assessment 2025

  Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.

• Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery

  Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.