Business Process Management

WHITE PAPERS AND CASE STUDIES

• 5 Must-Haves For Electronic Batch Records In Life Sciences

  Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Enabling Simpler, Quieter, And More Precise Wearables Utilizing Disruptive Pump Technology

  Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

• 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.

• 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.

• 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.

• Redefining The Analytical Frameworks Surrounding Capsid Characterization

  Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.

• Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility

  Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

• 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.

• The Key To Viral Vector Success

  Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

• 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.

• 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.