Guest Columns

  1. Model-based Control In Continuous Manufacturing Of Biotherapeutics: The Role Of Process Integration 11/24/2021

    In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved and uniform product quality, lower capital cost, and easy scale-ups. The primary focus, thereby, lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address the dynamically changing conditions.

  2. The 2 Emerging Fields Propelling The Use Of AI In Precision Medicine 11/22/2021

    Advances in AI-based analysis paradigms have created an unprecedented momentum in computational medical imaging applications, giving rise to new areas of precision medicine research. This article examines how recent medical imaging advances in oncology are bringing about new areas of precision medicine and previews its full potential.

  3. Can Real-World Evidence Transform Healthcare? FDA Activities Indicate Yes 11/19/2021

    Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

  4. Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry 11/17/2021

    More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.

  5. Demystifying Blockchain-Supported Smart Contracts 11/15/2021

    Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.

  6. Juno v. Kite Case Implications For Functionally Claimed Biological Compositions 11/12/2021

    The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?

  7. Model-Based Control In Continuous Manufacturing of Biotherapeutics 11/10/2021

    During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.

  8. Opportunities For Implantable Drug Delivery To Modernize Drug Therapy 11/8/2021

    The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.

  9. How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins 11/3/2021

    Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.

  10. Marks Took On FDA Vaccine Leadership Position – What Happens Now? 11/2/2021

    Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.