Business Process Management

WHITE PAPERS AND CASE STUDIES

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• Digital Transformation Optimizes Production, Quality, And Compliance

  Discover how advanced automation solutions at Fermion's new facility were implemented to enhance production, quality, and compliance in pharmaceutical manufacturing while meeting industry standards.

• 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.

• The Importance Of Understanding Materials In Medical Product Development

  Explore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.

• 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.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Unravelling The Complexities Of ADC Manufacturing

  Whether you're in the early stages of development or scaling up for commercialization, understanding ADC manufacturing challenges is essential for bringing life-saving therapies to patients worldwide.

• Intro To USP <1062> - What It Is And Why You Should Use It

  Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

• 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.

• Increase Production Capacity With Virtualized Process Automation

  Learn how Sleeman Breweries grew their production, improved process control, and avoided the high expense of building a new greenfield facility.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

• 7 Critical Factors For Predictable Quality In Medical Device Manufacturing

  Quality medical device production requires diverse engineering expertise, electronic integration, and a proven track record across seven key elements.