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WHITE PAPERS AND CASE STUDIES

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• 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.

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• Navigating The European Market's Regulatory Complexities

  Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.

• Restarting A Manufacturing Campus And Revitalizing A Community

  A high‑risk facility acquisition in Huntsville became a blueprint for revitalizing a modern pharmaceutical campus. Discover how coordinated action turned a massive shutdown into a renewed manufacturing hub.

• AMERICAN And Partners Install Boltless Restrained Underwater Pipeline System In Ashland, Wisconsin

  Beneath the waters of Chequamegon Bay on Lake Superior in Ashland, Wisconsin, about 4,500 feet of 24-inch AMERICAN Flex-Ring Ductile Iron Pipe and a submerged timber crib intake structure were installed to ensure the city’s residents have quality drinking water for the next 100 years. The Ashland Water Intake Project began May 1, 2025, and is now complete.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• Pharma Custom Isolator For Sterile Lab Process

  This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.

• 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.

• What Made The Becancour Water Treatment Plant A Model For Clean Water Solutions?

  Learn how Quebec’s Becancour Water Treatment Plant improved ozone efficiency, reduced maintenance, and enhanced scalability by upgrading to a modular Pinnacle Summit ozone system.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.