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WHITE PAPERS AND CASE STUDIES

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

• Closing The Gap In Our Understanding Of Sleep Health With DHTs

  What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Expanding The OSD Toolbox: An Industry Approach To Adsorb Lipids Onto Powder Substrates

  Explore innovative solutions for improving the solubility and bioavailability of poorly soluble compounds in solid oral dosage forms to enhance drug delivery and therapeutic effectiveness.

• Progressing A Cystic Fibrosis Treatment With A Strong Culture Match

  Collaborate with an experienced CMO that combines transparency, expertise, and a shared commitment to help advance complex biologics from preclinical research to clinical success.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• 3 Themes And Takeaways From FDA's Draft Guidance On DCTs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

• How ABB's Flow And Digital Technologies Help Bawat With Smarter Ballast Water Compliance

  The International Maritime Organization (IMO) sets strict global standards for ballast water management to prevent the spread of harmful aquatic organisms. For companies like Bawat, a Danish innovator in ballast water management, being able to verify ballast water flow measurements quickly, accurately, and from anywhere in the world is essential.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Reducing Complexity In Data Center Cooling Temperature Measurements

  Endress+Hauser’s iTHERM SurfaceLine TM611 non-invasive temperature measurement performs comparably to traditional industrial thermometers with an elegant mechanical innovation.

• Standardizing Content Management Across The Life Sciences Industry

  Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

• 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.