Industry Insights

  1. A Practical Approach To Regulatory Compliance And Market Success 5/29/2026

    Regulatory and quality compliance are built into every stage of biologics development, helping ensure consistent manufacturing, faster approvals, and dependable global market access.

  2. 3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche 10/11/2024

    Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

  3. Unlocking Value In Biopharma Operations: A C-Suite Call To Action 7/9/2025

    Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.

  4. Europe's ATMP Opportunity Still Requires Local Navigation 8/27/2026

    European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

  5. Testing And Selecting A Detergent Cleaning System 4/26/2023

    Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, follow along as we walk through those steps to help you optimize your cleaning process.

  6. Improve Scalability And Manufacturability Of A Cytotoxic ADC

    Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

  7. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  8. ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis 12/11/2024

    Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

  9. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities 6/29/2023

    These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.

  10. What FDA Inspectors Want From Your OOS File 9/16/2026

    Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.