Guest Columns

1. Ask The Pros — The Latest In HCP Monitoring 12/4/2025

   Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.

2. An End-To-End Automated HTP Platform For Cell Line Optimization 11/20/2025

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

3. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

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

4. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

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

5. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   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.”

6. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

   The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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

7. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

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

8. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

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

9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

10. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

    Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.