GUEST COLUMNISTS

• Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development

  The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

• How To Improve Sponsor–CMO Collaboration Around Digital Deviations

  Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

• Solving The Stem Cell Consistency Conundrum With iMSCs

  The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.

• Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach

  Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

• Exploring The Benefits Of Electroporation In NK Cell Transfection

  Electroporation creates temporary holes in cell membranes for genetic material to slip through. The technique offers some key advantages to viral transduction.

• On The Potency Assurance Journey, Travelers Need A Road Map

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

• It's Not Just You, Everyone's Talking About OPV

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

• Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs

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