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WHITE PAPERS AND CASE STUDIES

• Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

  Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

• Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow

  Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.

• Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1

  Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• Modernizing Clinical Trial Oversight: The Path To Clinical Operations Excellence

  Examine the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.

• Patient Selection By Anti-AAV Total Antibody Binding

  Advance the future of medicine by harnessing AAV-based gene therapies — powerful delivery systems that drive safer, more effective, and potentially curative treatments for genetic disorders.

• Working Smarter: Empowering Water Operators With Integrated Data

  As water utilities face the challenges of sustainability, efficiency, and service quality, digital technology has become a necessity. The right tech can help deliver reliable service, optimize systems, and meet sustainability goals, but integrating the data streams these solutions generate can offer even greater gains – allowing utilities to move faster and achieve more powerful outcomes.

• Rapid Results In A High-Stakes Dry Eye Disease Trial

  This time-sensitive Phase 3 trial in dry eye disease required precision project management leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.

• Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes

  The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.