Insights On Regulatory Compliance

  1. Success Story: Increased Productivity With Concentrated Fed-Batch 6/30/2025

    Discover how a leading biopharma company boosted flexibility and quadrupled productivity by implementing a concentrated fed-batch process in a single-use facility.

  2. Maximizing Results For Viral Clearance Studies 7/25/2025

    Explore virus strain selection and titer strategies to optimize viral clearance studies, covering regulatory expectations, study design, and execution best practices.

  3. Top 3 Mistakes Companies Make During Sterilization Validation 5/27/2025

    Sterilization validation is essential for product safety and compliance. Discover the top three mistakes companies make and learn practical strategies to avoid delays, non-compliance, and patient safety risks.

  4. What Indications Can, And Will, mRNA Therapeutics Address? 12/5/2023

    During our Bioprocess Online Live event, mRNA Update: Beyond Prophylactic Vaccines, we asked an audience of several hundred biopharma professionals what indications they’re addressing in mRNA therapeutic development. Here, our panelists address their responses and offer final thoughts on unfolding mRNA regulatory frameworks.

  5. How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs 10/24/2024

    Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

  6. Building A Strong Safety Culture In The Biopharmaceutical Industry 1/25/2025

    Explore how fostering a strong safety culture — rooted in accountability, collaboration, and proactive risk management — can drive operational excellence and long-term success in biopharmaceuticals.

  7. Boost Compliance And Efficiency With Real-Time Asset Management 9/2/2025

    Explore a platform that empowers GMP-regulated industries with a unified EAM, CMMS, and APM platform to boost compliance, efficiency, and asset performance through real-time integration.

  8. Nitrosamine Impurities Deadline: Are Your Products Compliant? 12/5/2023

    Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.

  9. Tips For Tracking And Recreating Your Golden Batch 9/18/2025

    Discover how pharmaceutical manufacturers are using digital tools to achieve the “golden batch”—a production run that balances quality, efficiency, and compliance through smarter processes.

  10. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.