GUEST COLUMNISTS

• USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli

  Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

• Are We Witnessing A New "Age Of The CDMO"?

  Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

• The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond

  These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

• Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies

  The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

• Is The BIOSECURE Act The First Real Step Toward Reshoring?

  The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

• Defining When To Implement Technologies To Support Commercial Growth

  Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

• 3 Focus Areas To Transition From Clinical To Commercial Readiness

  Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.