Industry Insights

  1. Modularity And Mobility Hold The Keys To Surge Manufacturing 11/30/2022

    When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

  2. What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices? 2/23/2022

    This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.

  3. Solving Atypical Protein Expression With Transposases 1/21/2026

    To optimize productivity and avoid costly delays for complex proteins, researchers should leverage flexible platforms and experienced CDMOs in cell line development.

  4. Advantages Of Working With An Embedded CMO

     An embedded CMO offers many advantages over other CMO models, not least its access to the extensive capabilities and knowhow of the parent organization.

  5. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

  6. Unlock The Potential Of Autologous CGT Through Digital Transformation 10/21/2025

    Scaling autologous CGTs requires more than technology—it demands digital precision. Learn how life sciences leaders are building future-ready manufacturing environments with advanced digital strategies.

  7. Unraveling The Complexity Of Tech Transfers 6/1/2023

    What if there was a better way to take data — digital or not — and convert it to a consistent format that can drive the digital thread for tech transfers?

  8. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

  9. Manufacturing Process Transfer: Challenges And Keys To Success 11/18/2022

    A successful technology transfer sets the stage for GMP production and opens the door to process performance qualification campaigns and licensure.

  10. The Future Is “Cloudy” For Data Integrity In Life Sciences 11/29/2016

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.