GUEST COLUMNISTS

• Global Implications Of Zero Tariffs On Indian Pharma Exports To China

  Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

• M&A In GLP-1 Technology: Practical Recommendations And Best Practices

  With explosive demand, expanding indications, and rapid innovation, the GLP-1 revolution is reshaping dealmaking. Here's a practical guide for companies negotiating M&A in this arena.

• Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots

  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.

• The Transition To E-Labeling Is More Than Uploading PDFs

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

• 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.