Business Process Management

WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Open-Label Study Assessing Relative And Absolute Bioavailability

  Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

• CHA Consulting Is Helping Florida Utilities Meet Ambitious Reclaimed Water Effluent Regulations

  Discover how CHA Consulting has been working to help utilities across the sunshine state find the right balance and stay ahead of statewide deadlines for compliance.

• Enhancing Preclinical Cell Therapy Development

  Automation in cell therapy development boosts reproducibility, reduces error, and enhances yield. Learn how it’s reshaping preclinical workflows and accelerating clinical trial readiness.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Office Of Naval Research Contract Leads To New Chlorine Sensor Technology

  Developed from U.S. Office of Naval Research requirements, this multiparameter chlorine sensor offers extended maintenance-free operation, flow-independence, and automatic compensation for reliable, in-pipe monitoring.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• 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.

• Offline eCOA: The Real-Time Monitoring Dilemma

  Balance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.

• Five Essentials For Accurate Oligonucleotide Chemistry

  Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.