Production Featured Articles

  1. How To Lose A Batch In 10 Days 9/25/2023

    Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations. 

  2. Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development 9/14/2023

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

  3. Continuous Processing For Enhanced Monoclonal Antibody Production 9/14/2023

    Explore highlights from a recent webinar where experts from Cytiva and Chugai Pharmaceutical, a Roche company, discussed their unique collaboration for the continuous processing of mAbs.

  4. Discover The Intricacies Of Molecular Landscapes Through QMSI 9/13/2023

    Explore quantitative mass spectrometry imaging (QMSI) and leading spatial bioanalysis and biology services that offers one-on-one support throughout your drug development process.

  5. Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture 9/13/2023

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

  6. Using Media And Feed Panels During Media Development 9/12/2023

    Find out how a panel-based approach can help accelerate cell culture media and feed development and maximize the productivity of your biopharmaceutical manufacturing process.

  7. Survey Results Show What Could Finally Make Sustainability Stick 9/8/2023

    Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.

  8. Have You Adopted A Manufacturing Execution System Yet? 9/7/2023

    Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.

  9. Increasing Delivery System Flexibility Through Solvent-Based Processing 9/5/2023

    Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug eluting carrier with a wide variety of APIs.

  10. Considerations For High Potent API Safety And Production 9/5/2023

    Working with High Potent Active Pharmaceutical ingredients (HPAPIs) requires thorough risk assessment, fit-for-purpose facility design, and significant investment in equipment and installations.