Industry Insights

  1. Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty 11/13/2020

    Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

  2. Logical Scale Out Before Scale Up 2/24/2025

    Explore how synthetic biology and a "scale-out" biomanufacturing strategy can unlock "infinite diversity in infinite combinations," optimizing MSC functionality for superior outcomes.

  3. Safe Handling Of Monoclonal Antibodies: Best Practices 3/7/2024

    Explore safety measures for handling mAbs in production in order to meet strict requirements that prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes.

  4. A Better Path For CMO Relationships As The Pandemic Continues 4/6/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

  5. Avoiding IT Outages With Continuous Cleanroom Monitoring Technology 8/13/2024

    Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.

  6. Selecting The Right Single-Use Materials In Biopharmaceutical Manufacturing 9/1/2023

    Manufacturing operations are getting a boost thanks to single-use technologies, but how do biopharmaceutical manufacturers choose the right materials for constructing their single-use solutions?

  7. Maximizing The Project Managers' Sphere Of Influence In Life Sciences 8/30/2022

    Learn how a project management process that works across disciplines can help coach, improve, and inspire others in that method to help them get the business value they need.

  8. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

    The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

  9. 21 New Downstream Technologies Being Considered To Fix Capacity Problems 1/25/2024

    Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.

  10. Increase Agility By Integrating Drug Substance And Drug Product 1/9/2026

    Biopharma success depends on agility. Move efficiently from discovery to delivery by co-locating drug substance and drug product operations, reducing transfer risks and accelerating your timeline