GUEST COLUMNISTS

• Import Product Specifications And Drug Registration Testing For China

  This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

• Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies

  The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

• What If We Had Just One Developability Parameter?

  Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

• Trust But Verify: Validating AI In Pharma's GxP World

  Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

• What You Should Know About USP's Bioassay Updates

  The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

• Derisking AI Means First Asking: Who Does It Serve?

  Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

• A Study In Optimizing Late-Stage Processes With QbD, DoE

  Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

• Key Considerations For Materials And Components Used In CGT Manufacturing

  This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.