GUEST COLUMNISTS

• An End-To-End Automated HTP Platform For Cell Line Optimization

  Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.

• Here's What You Need To Know About The Access Consortium Pathway

  Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

• FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK

  The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

• Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

  A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

• 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  The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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.

• 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.