Featured Bioprocessing Editorial

1. 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.

2. The Transition To E-Labeling Is More Than Uploading PDFs 10/31/2025

   Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.

3. 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.

4. Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes? 10/27/2025

   Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.

5. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

   Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.

6. Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry 10/24/2025

   Among other benefits, the approach can help compare CAR constructs, evaluate the effects of manufacturing processes, and monitor changes in protein interactions.

7. Program Manager Alignment And Integration: Best Practices When Working With A CDMO 10/23/2025

   This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

8. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

   The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

9. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

   The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

10. 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.