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1. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

   Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

2. How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides 10/21/2025

   A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.

3. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

4. 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.

5. 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.

6. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

   Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.

7. Weight Of Evidence Assessments For Carcinogenicity Studies: An Overview 8/20/2025

   Carcinogenicity assessments often rely heavily on two-year rodent bioassays. The weight of evidence (WoE) approach seeks to streamline this process, combining thorough science with regulatory practicality.

8. Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing 8/19/2025

   Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

9. The Building Blocks Of A Robust Analytical Assay 8/1/2025

   Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

10. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.