Expert Insights On Upstream Bioprocessing

61. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

62. Single-Use Bioreactors Gain Popularity Worldwide 9/29/2023

    Industry momentum is trending in favor of single-use bioreactors as a plurality of biopharma companies are opting for the disposable version of bioreactors, according to new market research. Let's look at the drivers of this change, regional analysis, and prominent vendors in the space.

63. 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. 

64. Guidelines For mRNA Drug Product Manufacturing And Quality Control 9/15/2023

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

65. USP Unpacks The Evolving HCP Identification And Quantitation Story Behind <1132.1> 8/18/2023

    Traditional ELISA methods can fall short of detecting some host cell proteins, so the United States Pharmacopeia has proposed a new general chapter to account for the increased use of mass spectrometry in conjunction with HCP ELISA.

66. Mechanistic Modeling To Optimize rAAV Production For Gene Therapy 8/11/2023

    Current processes in recombinant adeno-associated virus (rAAV)-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and you can use it to test a wide range of conditions and hypotheses.

67. Balanced Sourcing Of Custom Media/Buffer Formulations: The Case For Outsourcing 8/10/2023

    Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.

68. An Independent Expert's Guide To Picking Nanoparticle Manufacturing Equipment 7/26/2023

    Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.

69. Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach 7/20/2023

    Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.

70. Here's How USP mAb Standards Support Fast-Evolving Platform Approaches 5/24/2023

    Industry-accepted reference materials give drug manufacturers a competitive edge. Data shows that first-in-class mAbs hold a market lead over later entrants. This article discusses the benefits of using well-characterized reference materials instead of spending time and resources to develop them from scratch.