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WHITE PAPERS AND CASE STUDIES

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• 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.

• 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.

• High-Quality Serum to Improve Performance And Supply Stability

  A consultative partnership brought valuable solutions to a global CDMO that was experiencing performance issues with their fetal bovine serum, and needed a new product source of superior quality fast.

• 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.

• Analytics–Powered Approach To Patient Recruitment Strategy

  In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

• eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality

  Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.

• 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.

• Biopharma In Non-Footprint Countries Gets Support

  Uncover how this tailored solution helped a multinational pharmaceutical and biotechnology firm to develop an in-country presence and expertise, which was critical to meeting their study timelines.

• 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.

• 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.

• Preparing CRAs For Success In Oncology: Targeted Training In An Era Of Advanced Therapeutics

  Explore the pivotal role of Clinical Research Associates (CRAs) in oncology clinical trials, emphasizing their critical responsibilities and the importance of specialized CRA training programs.