Featured Editorial

1. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

2. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

   Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

3. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

   AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

4. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

   As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

5. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

   Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

6. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

   Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

7. 4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs 3/6/2025

   Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.

8. The Rise Of AI-Powered Drones In Clinical Logistics And Supply Chains 3/5/2025

   Drone technology has significantly advanced, benefiting from improved connectivity, GPS accuracy, and AI/ML.

9. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

   The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

10. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.