High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Full Scale Operations For Parenteral Pharmaceuticals

  Explore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.

• Achieve Higher Targeted Concentrations

  Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

• Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

  A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

• Simplify CAPA In 7 Steps

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

• A New Approach To Characterizing Crystalline Structure

  Learn how the accuracy (melting temperature and heat of fusion) and utility of Differential Scanning Calorimetry data is greatly diminished for materials that undergo Apparent Melting and much more.

• Top Biopharma Enhances Regulatory Efficiency

  Learn how this biopharma company was able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, significantly reducing errors and improving data management.

• Medical Device Manufacturer Implements A Next-Gen MES

  A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.

• 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.

• Bridging The Gap During Organizational Restructuring For Continuity

  Navigating workforce turnover and restructuring can threaten project timelines. Discover how leveraging an experienced on-site team can ensure long-term continuity.

• 6 HUBER Coarse Screen TrashMax® For Flood Protection In Houston, Texas

  In response to Hurricane Harvey, the Fort Bend, TX Levee District No. 2 embarked on a major upgrade project to increase the flow and capacity of one of its pump stations by 400%. The goal of the project was to protect the area around the district from 100- year floods in the future.

• 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.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.