Guest Columns

  1. What You Should Know About USP's Bioassay Updates 10/2/2025

    The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

  2. Automation In The Lab: Lessons From Successes And Setbacks 9/24/2025

    Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.

  3. Can CHO Bioreactors Be Used For Plant-Based Protein Production? 9/22/2025

    The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.

  4. How To Grow CHO Cells Without Cysteine, Tyrosine Feeds 9/19/2025

    Researchers at Pfizer are developing a cell line that synthesizes these amino acids autonomously, which could reduce costs and increase stability.

  5. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

    FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

  6. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

    The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

  7. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

  8. The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma 9/15/2025

    As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.

  9. How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage 9/15/2025

    It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.

  10. What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish 9/11/2025

    Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.