Best of February: Top 5 Insights In Clinical Supply Chain & Logistics

#1 - 2024 Trends In FDA Observations For Sterile Drug Manufacturers

This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

#2 - RTSM/IRT In Clinical Trials: The Complete Guide

This guide explores how to implement and optimize RTSM/IRT systems to boost efficiency, streamline operations, uphold study integrity, and ensure compliance.

#3 - ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them

Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.

#4 - A Custom IRT System Facilitates Precision Medicine Studies

As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.

#5 - 10 Ways To Speed Up CMC In Early-Stage Drug Product Development

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