Industry Insights

  1. Utility Of GMP Next-Generation Sequencing (NGS) For Biosafety Assessment Of Biological Products

    By delivering significantly more data than traditional Sanger-based sequencing methods, NGS opens a range of possibilities for the analysis of diverse DNA and RNA populations.

  2. Cell & Gene Therapies: A Guide To Single-Use Connections

    This article captures high-level learning about the use of SUTs in biopharmaceutical manufacturing that can be applied to CGTs, with a special focus on connection technologies.

  3. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  4. A Call To Action For Pharma CMOs

    The traditional CMO business model, with multiple clients sharing the same tightly scheduled production trains, is not adaptive; it is a one-size-fits-all solution.

  5. Rise In Targeted Therapies Drives Need For Flexible, Small-Volume Manufacturing

    Biologics, orphan drugs, and precision medicine are on the rise and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy.

  6. Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  7. Biosimilar Manufacturer Builds Facility Designed For Drug Cost Savings

    Alvotech facility features a high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.

  8. Key Considerations When Sourcing Reference Products For Biosimilar Studies

    In order to ensure a smooth development and clinical process, companies must carefully plan their activities with regard to the innovator biopharmaceutical. 

  9. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  10. Getting Ready For Phase 1 In Pharmaceutical Development

    At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.