MilliporeSigma Articles

  1. De-Mystifying Regulatory Support During Viral Vector-Based Development 4/15/2025

    Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

  2. Navigating Next-Generation Quality Control Strategies For AAV Testing 3/10/2025

    AAV-based gene therapies, while promising, require rigorous quality control through advanced methodologies to ensure safety, efficacy, and regulatory compliance.

  3. Key Regulatory Considerations For The Next Wave Of Gene Therapies 2/21/2025

    The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

  4. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  5. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

  6. Integrated Approach In Managing CPV And APQR 11/12/2024

    Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

  7. The Key To Viral Vector Success 11/11/2024

    Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

  8. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  9. Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development 10/7/2024

    Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

  10. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.