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WHITE PAPERS AND CASE STUDIES

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• 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.

• Designing Protocols For A 40% Emulsifiable Concentrate Of A Systemic Insecticide

  Explore how formulation expertise can help overcome the complex challenges of developing stable, effective, and regulatory-compliant emulsifiable concentrate (EC) formulations for crop protection.

• Metropolitan Sewer District Of Greater Cincinnati

  The Lower Mill Creek Partial Remedy (LMCPR) in Hamilton County, Ohio, is a large, complex effort to remove about 1.78 billion gallons of combined sewer overflows (CSOs) annually from the Mill Creek, an Ohio River tributary. When complete, LMCPR will improve water quality and serve as a catalyst to improve local neighborhoods.

• ATAD Provides Increased Capacity With No Odors

  Faced with persistent odor complaints and limited space, Douglas County Sewer District #1 in East Wenatchee, Washington, turned to the ThermAer second-generation Autothermal Thermophilic Aerobic Digestion (ATAD) system to modernize its biosolids treatment.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• Global Start-Up For Multinational Geographic Atrophy Trial

  This partnership allowed a leading biopharmaceutical company to navigate the complexities of a Phase IIb study investigating a novel pegylated RNA adapter for geographic atrophy secondary to dry AMD.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• Creating Sustainable Data In The Laboratory

  In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.

• Guide To Seeding, Expanding, And Harvesting Stem Cells

  Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.