Expert Insights On Downstream Bioprocessing

81. Considerations For Robust Implementation Of The Multi-Attribute Method 3/19/2024

    USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.

82. Getting To Know MAM, The New Quality Control Strategy On the Block 3/11/2024

    When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.

83. 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. 

84. Tangential Flow Filtration 101 — The Tech, The Need, And The Market 1/26/2024

    Here's a high-level summary of what is increasingly becoming an essential part of the downstream bioprocessing production line.

85. Picking The Best Virus Sample Prep Method In Process Development 1/26/2024

    Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.

86. 21 New Downstream Technologies Being Considered To Fix Capacity Problems 1/25/2024

    Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.

87. 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.

88. 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.

89. 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. 

90. 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.