BIO From The Editor and Guest Columns

  1. Release Testing Of AAV Gene Therapies For Clinical Trials 11/29/2023

    Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.

  2. How Can Digital Twins Get Us Closer To Pharma 4.0? 11/28/2023

    Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.

  3. Your 6 Priority Areas For A Successful 2024 11/27/2023

    As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.

  4. Biotech Dealmaking With Regeneron's Nouhad Husseini 11/22/2023

    Partnerships, acquisitions, licensing agreements, and other deals with Intellia, Decibel Therapeutics, BARDA, Alnylam, and Sonoma Therapeutics are just a sampling of Regeneron's strategic partnerships making news this year. Nouhad Husseini, SVP and Head of Business Development and Corporate Strategy at Regeneron is behind much of the dealmaking.

  5. 6 PEG Alternatives You Should Be Thinking About 11/22/2023

    PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.

  6. A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time 11/22/2023

    This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.

  7. 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.

  8. Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging 11/21/2023

    Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?

  9. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

  10. Backpacks And Biotech With Luke Timmerman 11/19/2023

    From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. In this episode, we'll get to know Luke personally, learn about his philanthropic work, and give you a healthy dose of optimism as we look ahead to the next decade in biotech.