Featured Outsourcing Editorial

31. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

32. It's Not Just You, Everyone's Talking About OPV 11/12/2025

    Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

33. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

    This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

34. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

35. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

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

36. M&A In GLP-1 Technology: Practical Recommendations And Best Practices 11/4/2025

    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.

37. 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.

38. 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.

39. 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.

40. 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.