Featured Bioprocessing Editorial

  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. Trends In Single-Use System Adoption In The Biopharma Industry
    6/10/2019

    Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    5/28/2019

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  9. “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.

  10. 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.