GUEST COLUMNISTS

• Are You Still Evaluating CMOs When You Really Need A CDMO?

  Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

• Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?

  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.

• Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs

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

• Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry

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

• Program Manager Alignment And Integration: Best Practices When Working With A CDMO

  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.

• New Guide Aims To Build Robust Framework For Digital Validation Tools

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

• Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms

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

• How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides

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