Contributing Editors

  1. What To Do When Your CDMO Receives A Warning Letter
    6/11/2019

    You have just completed a full technical transfer to a CDMO for your commercial drug product. This has been a two-year program and you are gearing up to launch the opening campaign. Then, the regulatory team from the CDMO alerts you that it has been issued a warning letter by the FDA.

  2. 7 Tools For Breakthrough Quality And Performance In 30 Days
    6/7/2019

    In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.

  3. Equipment Change Control For GMP Production Facilities — How To Start
    6/5/2019

    While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.

  4. Essential Points To Consider For Better Microbial Data Deviation Investigations
    6/3/2019

    Microbial data deviation investigations are notoriously difficult to perform. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial.

  5. Is Continuous Manufacturing Right For Your Drug?
    5/30/2019

    Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

  6. Could Microbiome-Based Therapies Upend The Asthma And COPD Markets?
    5/28/2019

    Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets. 

  7. “Work Harder” — And Other Ways To Completely Miss The Mark On Quality
    5/24/2019

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

  8. Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
    5/21/2019

    BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting. 

  9. 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
    5/14/2019

    It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets. 

  10. Military Tool For Vulnerability Assessment: The CARVER + Shock Technique
    5/13/2019

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.