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WHITE PAPERS AND CASE STUDIES

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• 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.

• Optimal COA Measurement Strategy In Modern Oncology Trials: Insights

  Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.

• Revolutionizing Biofilm Research: High-Resolution, Real-Time Imaging with ZeGage Optical Profiler

  A university lab optimized biofilm research with Zygo’s ZeGage Optical Profiler, enabling high-resolution, real-time, non-contact imaging that accelerates data collection, enhances accuracy, and preserves biofilm integrity.

• Intelligent Automation For MDR & IVDR Content

  Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance.

• Multiple Fill Line Delivery Experience

  Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• 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.

• Navigating The European Market's Regulatory Complexities

  Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.

• Revolutionizing Pharmaceutical Quality Control

  Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

• 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.

• Validating New Identification Algorithms With Objective Criteria & Clinical Trial Data

  Learn how researchers and clinicians can make better-informed decisions to advance patient care and enhance public health outcomes related to myocardial infarction.