Industry Insights

  1. Detection And Quantification Of Process-Related Impurities 6/1/2023

    Finding a partner with the expertise and capabilities to provide solutions for detecting and quantifying process-related impurities ensures the successful development and manufacturing of safe and effective products.

  2. 2022 Outsourcing Trends In Biopharmaceutical Manufacturing 6/15/2022

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

  3. A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs 3/12/2021

    Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations. 

  4. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

  5. Risk Management in Web Clinical Trials 3/6/2000
    Have you thought about risk management in your Web clinical trial? What are the risks?...
  6. How Digitalization Helps Manufacturers Overcome Operational Challenges 8/9/2024

    Discover how digitalization can offer better control and increased speed for cell and gene therapy manufacturers.

  7. Are You Still Evaluating CMOs When You Really Need A CDMO? 10/29/2025

    Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

  8. 5 Ways A QMS Reduces Cost Of Poor Quality 4/4/2025

    Discover how a robust Quality Management System can help your organization reduce the cost of poor quality while maintaining high standards and enhancing customer satisfaction.

  9. Tips For Building A Voluntary QA Culture In A 2021 COVID World 12/21/2020

    As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

  10. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.