Industry Insights

  1. Alliances at the margins: Board out of your mind 1/23/2001
    The deal is signed, now it's time to make it work...
  2. 6 Core Capabilities Your Digital DHR Must Have 11/14/2022

    In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA.

  3. Optimize mAb Process Development To Reach Your Goals Quickly 5/6/2025

    In the pursuit of making your mAb process as efficient as possible, it is vital to identify the cell line, media, feed, and resin that best suit your productivity goals.

  4. The Role Of Quality By Design In Pharmaceutical Tablet Development 7/30/2024

    Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

  5. Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences 12/6/2022

    Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.

  6. Does Your CDMO Have Sustainable API And RSM Strategies?

    How can you be sure the CDMO you select has appropriate oversight and management of their RSM and API manufacturing supply chain, so you do not experience costly delays?

  7. A Smarter Strategy For Optimizing Oncology Drug Products 7/14/2023

    John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.

  8. Spatial Biology: Learning The Landscape 1/8/2024

    Biological research is changing with a growing understanding of spatial biology, including the organization and interaction of molecules, cells, and tissues in their native spatial context.

  9. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

  10. Get More Insight And Value Out Of Your Electronic Batch Record Data 2/2/2024

    Explore a cloud-based alternative to Electronic Batch Record (EBR) software that is well-suited for small to mid-sized biotech or CGT companies.