Industry Insights

  1. Executing Signals And Responses In A Continued Process Verification Program 12/18/2019

    Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

  2. Bayer's Supply Network-Centric Approach To Digitalization 12/5/2024

    Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here's how one company is approaching the monumental task.

  3. Celebrating Collaborative Success With 2023 CDMOs 12/19/2023

    MasterControl congratulates its customers recognized as top CDMOs in 2023. These leading organizations are driving innovation and delivering high-quality therapies through the power of technology.

  4. The Write Side Of AI: Augmenting Capabilities, Not Replacing Them 3/1/2024

    AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

  5. Add Efficiency From Development To Validation With Design Of Experiments 3/10/2023

    A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.

  6. Unboxing Genentech's New Clinical Supply Center 8/28/2023

    Genentech’s Clinical Supply Center, which opened in 2022 in South San Francisco, earned the company an ISPE Facility of the Year Award in the Pharma 4.0 category. This Q&A, the third in a series featuring FOYA winners, explores the strategy behind a central manufacturing site for clinical manufacturing.

  7. CBER Takes On More Oversight Of Biologic Biosimilar Master Files 8/11/2020

    For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.

  8. An Enabling Technology: Hot Melt Extrusion

    Whether you wish to improve the bioavailability, enhance the solubility, mask an unpleasant taste, modulate drug release, or address drug stability issues, extrusion can deliver on these objectives and more.

  9. Key Considerations In Optimizing Downstream Process Development For mAbs 5/8/2024

    Optimizing downstream process development for mAbs requires scientific expertise, careful planning, and rigorous testing. Delve into the essential steps and learn how to deliver high-quality mAbs.

  10. 4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage 8/25/2023

    It’s no secret that finding pharma/biotech manufacturing talent is challenging, and the lack of workers is having a negative impact on productivity and growth. Here are four effective strategies for recruiting, training, educating, and retaining your workforce.