MilliporeSigma Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Business Continuity Management: The Benzonase® Endonuclease Success Story 8/21/2024

    Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.

  9. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  10. Scaling Up The Learning Curve For Large-Scale AAV Manufacturing 7/26/2024

    The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.