Business Process Management

WHITE PAPERS AND CASE STUDIES

• Streamlining AAV And LVV Manufacturing Platform Solutions

  Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.

• 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.

• The Essential Role Of Adjudication Technology In Clinical Trials

  With adjudication, learn how teams can enhance the quality and integrity of their research, paving the way for impactful and reliable outcomes in clinical research.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• 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.

• Rethinking Peptones As First-Line Optimization Tools

  Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• 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.

• 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.

• 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.

• An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market

  Discover how an experienced CDMO offering a purpose-built facility with flexible capacity can help biopharmaceutical companies bring their products to market quickly and efficiently.

• CHO Cell Lines For Recombinant Protein Production

  Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.