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WHITE PAPERS AND CASE STUDIES

• Elevating Diverse Patient Voices To Inspire Clinical Trial Participation

  Explore the innovative approach taken during this clinical trial partnership to address the underrepresentation of minority communities in clinical trials through digital storytelling.

• The Effect Of Mixing Homogeneity In Retentate Vessel

  Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.

• Methods For Determining Equipment Capability Of Freeze-Dryers

  Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

• 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.

• Random And Semi-Targeted Integration In Cell Line Development

  While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

• 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.

• Reducing Complexity In Data Center Cooling Temperature Measurements

  Endress+Hauser’s iTHERM SurfaceLine TM611 non-invasive temperature measurement performs comparably to traditional industrial thermometers with an elegant mechanical innovation.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• 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.

• A Biosafety Cabinet For Virology Studies And Disease Surveillance

  Discover how Germfree tackled a unique challenge from the Public Health Agency of Canada by designing a custom Class III biosafety cabinet for advanced virology studies and disease surveillance.

• 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.

• 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.