Business Process Management

WHITE PAPERS AND CASE STUDIES

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process

  Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.

• Criticality And Risk Analysis Helps Mojave Water Agency Optimize Maintenance Activities And Realize Cost Savings

  Amid a decrease in water supply and reliability, the MWA has seen a rise in costs and operational challenges related to regional expansion, increased regulatory requirements, climate change, and aging infrastructures. Despite these challenges, the MWA remains committed to managing groundwater basins sustainably, importing water responsibly, and proactively addressing risks using sound scientific practices.

• The Impact Of Artificial Intelligence On CQV

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• Shedding More Light On Ultra-Wideband

  Discover how Ultra-Wideband (UWB) technology is revolutionizing manufacturing by providing unparalleled precision in locating products and optimizing processes for enhanced efficiency and safety.

• How A Strategic Partnership Drove Micro Molding Success

  In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling production program into a 150-million-part success through trust, scalability, and true strategic partnership.

• Comparative Analysis Of Batch And Continuous Processes

  Explore a comparative analysis that showcases the superior performance of continuous processing over traditional batch methods, highlighting key improvements in efficiency and environmental impact.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays

  Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

• Digital Innovation And Sustainability Are Redefining Biomanufacturing

  Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.