From 2 L to 2,000 L: what actually breaks when you scale a CHO process
We read 38 primary sources on CHO scale-up. The trouble at 2,000 L is on the gas side and at harvest, not in impeller eddies.
Single-use
AGC Biologics commits half of Yokohama’s mammalian capacity before the site opens
An undisclosed biopharma has booked half of the mammalian capacity at AGC Biologics’ Yokohama site: five products, 35+ batches a year, four PPQ campaigns in two years.
Cellares and SNUH test automated gene-modified HSPC manufacturing on the Cell Shuttle
Seoul National University Hospital will test moving its gene-modified HSPC process, with a two-step transfection workflow, onto Cellares’ automated Cell Shuttle.
EVA Pharma, DNA Script and Quantoom: what an end-to-end mRNA line in Egypt would involve
A February 2025 MoU targets an Egyptian platform for 100 million RNA vaccine doses a year. The three process blocks, the scale in kilograms, and what the release leaves open.
Sartorius and Sanofi’s continuous downstream platform: what the 2024 deal covers
Sanofi built the prototypes, Sartorius got exclusive rights to sell the platform. What the 2024 release says, what it leaves out, and what ICH Q13 asks a plant to prove.
Endonuclease-free AAV clarification: what the authors’ abstract and Solventum data show
Researchers report dropping the endonuclease step in AAV lysate clarification. What the authors’ abstract and the filter maker’s data show, and what a plant would still need to prove.