Business Process Management

WHITE PAPERS AND CASE STUDIES

• Digital Transformation And Quality By Design For Enhanced Development

  Discover how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.

• Understanding Ultrapure Water, Difficulties With pH Measurement

  By gaining insights into the diverse types of pH measuring analyzers and sensors, companies can make informed decisions to enhance their UPW management strategies and drive operational excellence.

• 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.

• The Role Of Hexapods In High-Precision Machining

  A custom hexapod was introduced at ILA Berlin 2024, enhancing precision in aircraft construction. This 6-DOF system improves contour machining of CFRP components, reducing manufacturing times and costs.

• Modern Modeling Tools For Small Molecule Solid Dose Manufacturing

  Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

• Early-Phase Injectable Formulation Development

  Discover how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

• 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.

• Outgrowing Excel: Implementing RTSM Software In A Live Phase I Trial

  Moving from manual spreadsheets to RTSM mid-study requires precision. Learn how clinical teams maintain trial momentum while executing protocol changes without delays.

• Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays

  Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

• Small Volume ATMP Cryo-Freezing Strategies

  Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

• 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.

• 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.