Expert Insights On Upstream Bioprocessing

51. 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.

52. 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. 

53. 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.

54. 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.

55. 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.

56. Achieving Flexibility In RNA Drug Manufacturing With Microfluidics 11/21/2023

    RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.

57. Why Lactococcus Lactis Might Be The Best Membrane Protein Factory 11/17/2023

    The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.

58. Building AAV Manufacturing Capacity For Large Patient Diseases 11/15/2023

    AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues could help companies clear away some of those obstacles. 

59. Modular And Single-use Tech Driving The Future Of Biomanufacturing 11/14/2023

    BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.

60. Understanding The Importance Of Real-Time Monitoring For Protein Aggregation 10/30/2023

    This article breaks down the advantages of real-time monitoring for protein therapeutics, including how it can accelerate timelines, produce better data, and smooth regulatory compliance.