Bioprocessing White Papers

  1. Cell Culture Process Scale-Up Challenges For Commercial-Scale PSC Manufacturing 3/5/2025

    Allogeneic cell therapies offer incredible promise, but scaling up PSC manufacturing presents unique challenges. Explore these hurdles along with solutions for consistent, high-quality production.

  2. Improving API Solubility 3/3/2025

    Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

  3. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  4. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  5. Supplier Quality And The True Cost Of Recalls 2/20/2025

    Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.

  6. Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis 2/20/2025

    Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.

  7. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

  8. Quality: The Link Between Platform, Processes, And Patients 2/18/2025

    Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.

  9. Connecting Quality Management, Patient-Centricity, And Business Value 2/18/2025

    Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

  10. Leveraging Life Sciences Data For Intelligent Decision-Making 2/18/2025

    Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.