Business Process Management

WHITE PAPERS AND CASE STUDIES

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• Revolutionizing Wastewater Management In Four Cities Through Water Mixing

  Historically, lift station operators have turned to chemical treatments as the primary means of managing grease buildup. However, these methods carry inherent drawbacks. 

• 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).

• 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.

• Elevating Downstream Process Development With Real-Time Data Monitoring

  Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

• Enabling The Future Of Intensified Biomanufacturing

  Process intensification demands smarter orchestration, real-time analytics, and scalable automation. Discover how digital infrastructure enables synchronized, compliant, and predictive biomanufacturing.

• Meeting The FDA's CAPA Expectations

  Year after year, deficiencies in corrective and preventative action procedures have consistently topped the list of the most common observations during FDA inspections. Gain insight on how to ensure your organization is CAPA-ready.

• Development Strategies For Adenovirus-Based Gene Therapies

  Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

• Converting iPSC To T Cells: Key Challenges And Considerations

  Explore how by addressing challenges in differentiation, clone selection, and manufacturing, iPSC-based T cell therapies could revolutionize cancer treatment and other diseases.