Expert Insights On Upstream Bioprocessing

51. How To Measure Cell Density In Real Time With Soft Sensors 3/21/2024

    Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.

52. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

    To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

53. Continuous Manufacturing: Many Want It, But Here's Why Few Have It 2/13/2024

    In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.

54. It's Time To Dethrone CHO When It Comes To mAb Production 2/1/2024

    Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.

55. Developing A Viral Gene Therapy Manufacturing Process 1/23/2024

    There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.

56. How To Use Precipitation, Not Protein A Chromatography, For mAb Capture 1/4/2024

    Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.

57. Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield 1/2/2024

    It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status. 

58. To Thrive In A Highly Regulated Manufacturing Environment, Improve Your Flexibility 12/19/2023

    It sounds counterintuitive. After all, industry must put (often rigid) rules into place to govern manufacturing processes and ultimately protect the integrity, efficacy, and safety of products. But by adopting process discipline to become more agile, you'll be able to respond to changes more quickly.

59. 4 Focus Areas To Improve AAV Production Lines 12/18/2023

    AAV-vectored drugs can potentially treat population-level diseases. But biopharmaceutical companies will have to get better at producing them in bulk. Here are some areas to focus on.

60. Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement 12/12/2023

    The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.