Industry Insights

  1. Developing & Implementing A Continuous Bioprocess Control Strategy 2/20/2024

    A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.

  2. 5 Answers To FDA Computer System Validation Questions 4/8/2022

    We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.

  3. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

  4. Unlock Efficiency: Leverage The Right Tools To Build Process Knowledge 2/3/2025

    The biopharma industry must shift from data collection to process knowledge, leveraging digital tools to optimize drug development, enhance quality, and streamline tech transfer through digital maturity.

  5. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

    Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

  6. Establishing The Right-Sized Tech Ops Strategy In An Uncertain Market 9/20/2023

    A quantitative and qualitative tech ops strategy gives biotech companies a sound roadmap to guide them through the winding road of drug development and attract investors.

  7. Process Validation For Pharmaceutical Manufacturers 9/18/2025

    Manufacturers must validate their processes to meet FDA standards and protect consumer safety. Explore how process validation ensures consistent product quality and is a cornerstone of compliance.

  8. Improve The Management Of Your Design Of Experiment Studies 9/10/2024

    Discover how a comprehensive DoE platform can streamline your drug development process and deliver high-quality results.

  9. A Blueprint For Breakthroughs: Accelerating Rare Disease Therapies 6/11/2024

    To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

  10. Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk? 3/4/2020

    In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.