GUEST COLUMNISTS

• Here's What Limits AI's Outlook For Replacing Knowledge Workers

  Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.

• How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much

  In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

• Tales From The Trenches: Developing Potency Assays Outside Big Pharma

  Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

• FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline

  The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

• Is Your Pharma Facility Ready For The Next Public Health Crisis?

  Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

• A Flexible Mindset For Bridging Between Cell-Based Assay Groups

  Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

• Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation

  Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

• Exploring Outsourcing's Role In CGT Scalability And Affordability

  CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.