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WHITE PAPERS AND CASE STUDIES

• 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.

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

• 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.

• 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.

• 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.

• 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.

• Simplify CAPA In 7 Steps

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

• Tailored Approach Supports Bladder Cancer Breakthrough

  Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.

• Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local Community

  In this case study, read how the Lunenburg Water District improved their water disinfection system with the installation of an Atlantium RZ300-11 HOD UV system. The system effectively disinfects water, meets future demands, and eliminates chlorine taste and odor.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Biotech Delivers A Superior Patient And Site Experience

  To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

• Labware Washing Techniques And The Sinner's Circle

  Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.