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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).

• Breaking Down Operational And Financial Complexity In Clinical Trials

  Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• 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.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Considerations For Developing The Recirculation/Perfusion Process

  Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• Scale Up Strategy For Oncolytic HSV-1 Vector Manufacturing

  Discover how a novel, large-scale production method for herpes simplex virus type-1 vectors has the potential to accelerate the progress of gene therapy and bring it closer to widespread application.

• How Digital Transformation In Sample Management Increases Efficiency

  Explore a real-world example of how a dynamic and growing CDMO implemented a lab management system to improve efficiency and data integrity for their quality control sample management workflows.

• If You Can't Win The Game, Change It

  Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

• 2nd Generation ATAD Provides Superior Treatment

  In a bold move to modernize its wastewater treatment, Bowling Green, Ohio, installed the state’s first second-generation Autothermal Thermophilic Aerobic Digestion (ATAD) system—ThermAer—in 2004. The upgrade expanded the plant’s capacity from 6 to 10 MGD and replaced an inefficient, odor-prone coarse-bubble aeration system.