Production Featured Articles

  1. Putting The “Process” Into Process Characterization
    3/19/2019

    Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.

  2. Tackling The Challenges Of Biologics Development And Manufacturing
    3/19/2019

    Biologics offer distinct advantages that small molecule drugs do not, but they are far more complex to develop and manufacture. Read why it is critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.

  3. Key Takeaways From The FDA’s New Continuous Manufacturing Guidance
    3/15/2019

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

  4. Not Your Grandma’s Aseptic Filling Line: Letting Go Of Tunnels, Washers, And Other Aseptic Vestiges
    3/8/2019

    We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. In each case, the receiving site is focused on schedule and budget. These competing targets often distract personnel from embracing newer technologies, bypassing lower-cost options and faster implementation. 

  5. Big Data And AI In Pharma Development And Manufacturing: An Inside Look
    2/27/2019

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

  6. Solving Problems More Effectively Than Sherlock Holmes: The Contradiction Matrix
    2/22/2019

    This is the fourth article in a five-part series on better investigation and problem-solving methods and principles in the life sciences. In writing this one, I’ve been thinking quite a bit about Sherlock Holmes. Not only his exquisite methods, but also flaws in the metacognition and metaphilosophy about how the fictitious detective underwent his work.

  7. How Technology Will Reshape The Future Of Aseptic Processing
    2/11/2019

    Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. 

  8. The Top 3 Forms Of Operational Overcomplexity In Pharma Manufacturing — And How To Simplify Them
    2/4/2019

    We like simplicity. Yet in pharmaceutical operations we have become very good at making things more complex than they need to be.  This article illustrates a few areas where companies tend to make matters worse and highlights areas where both industry and regulatory agency leaders should push back and focus on simplification.

  9. Why Now Is The Time For An Aseptic Processing Revolution
    12/27/2018

    This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.

  10. 3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?
    12/21/2018

    In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.