MilliporeSigma Articles

  1. If You Can't Win The Game, Change It 12/11/2024

    Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

  2. 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.

  3. 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.

  4. 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.

  5. Performance Characteristics Of The Mobius® ADC Reactor For Conjugation 10/22/2024

    Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

  6. A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk 10/10/2024

    Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

  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. Accelerating ADC Clinical Development Timelines 8/28/2024

    For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.

  9. Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy 6/11/2024

    RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

  10. The Evolution Of Antibody-Drug Manufacturing 6/3/2024

    Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.