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WHITE PAPERS AND CASE STUDIES

• Efficient Carbon And Ion Exchange Media Exchange

  This document outlines the essential steps required to exchange spent media, including disposal of spent media.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• 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.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Hot Water Disinfection For International Hotel Chain, Israel

  See how an Israeli hotel chain slashed energy costs by 27% while ensuring Legionella compliance through innovative UV water disinfection technology.

• 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.

• 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.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• 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.

• 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.

• Turnkey Dismantling, Modification, And Relocation Of A Multi-Glove Isolator System

  Strategic equipment relocation and retrofitting can reduce capital costs by fifty percent and save months in lead time. Learn how to modernize legacy systems while maintaining full GMP compliance.