Newsletter | December 3, 2025

Best of November 2025: Top 5 Insights In Clinical Supply Chain & Logistics

Clinical Supply Leader

TOP 5 INSIGHTS IN CLINICAL SUPPLY CHAIN & LOGISTICS  

NOVEMBER EDITION

#1 - Why Do So Few Cell Therapies Make The Leap From Lab To GMP?

Most cell therapies never reach GMP manufacturing because processes born in academic labs often don’t translate to scalable, closed, compliant production — leading to delays, redesigns, or stalled programs. Explore the root causes and practical steps to build manufacturability early so promising therapies actually make it to patients.

#2 - A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches

Scaling iPSC manufacturing exposes a major analytics gap, and this article explains how a modular multi-omics approach — anchored in qPCR and expanded into 3D assays — can finally connect 2D standards with clinically relevant 3D biology. Learn where characterization needs to go next.

#3 - Global Implications Of Zero Tariffs On Indian Pharma Exports To China

China’s removal of its 30% tariff on Indian medicines — just as the U.S. imposes steep duties on branded imports — is reshaping global pharma flows and shifting procurement strategies. This article breaks down the winners, risks, and tactical moves procurement teams must make now to stay ahead of this geopolitical realignment.

#4 - Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs

Accelerated mAb programs shorten timelines but shrink the window to build product-specific CMC knowledge, making a clear, risk-based control strategy essential for protecting product quality. Discover which upstream, downstream, filling, and analytical parameters truly matter and how teams can focus characterization efficiently.

#5 - What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish

Selecting the right sterile fill/finish CDMO can make or break a development program, and this article breaks down the must-have capabilities. If you’re planning a sterile program, these insights will help you avoid costly surprises and choose a partner who can truly protect your timelines and your patients.