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WHITE PAPERS AND CASE STUDIES

• 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.

• 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.

• 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.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• 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.

• 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.

• 3 Themes And Takeaways From FDA's Draft Guidance On DCTs

  Get our experts’ summary of recent regulatory guidance as well as recommendations for optimal decentralized clinical trial design and conduct.

• A Partnership To Deliver Excellence In Antibody Discovery And Production

  Explore the partnership that assisted FairJourney Biologics in methodically handling 30 to 40 different production projects concurrently.

• Drinking Water Disinfection In A New Hampshire Town

  The town of Hillsborough, NH chose Atlantium's HOD UV system to disinfect their drinking water due to its low disinfection by-products and reliable virus inactivation. Atlantium's UV technology is validated and offers stable and efficient water treatment solutions.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Cancer Research UK's Path To Rave EDC And The Medidata Platform

  Discover how Cancer Research UK, the world's largest cancer charity, upgraded to Medidata's Rave EDC platform, streamlining clinical trials and enhancing productivity while ensuring minimal disruption.