Cellares has entered a collaboration with Seoul National University Hospital (SNUH) to evaluate automated manufacturing for SNUH’s gene-modified hematopoietic stem and progenitor cell therapy for paroxysmal nocturnal hemoglobinuria (PNH).
The proof-of-concept work will focus on transferring SNUH’s manufacturing process to Cellares’ Cell Shuttle platform, including a two-step transfection workflow supported by Cellares’ fully integrated, single-use electroporation module.
The agreement is Cellares’ second collaboration in Asia and expands the company’s presence in the Asia-Pacific region. Cellares said the program is intended to support preclinical development and IND-enabling manufacturing as SNUH advances the therapy toward future clinical development in the U.S.
SNUH is developing gene-modified hematopoietic stem cell therapies in collaboration with global institutions. The partners aim to establish a scalable manufacturing strategy for the PNH program using automated, closed-system manufacturing.
“Advancing gene-modified HSPC therapies requires a manufacturing approach that can support both the complexity of the process and the rigor of clinical translation,” said Professor Youngil Koh, Director of the SNUH GMP Facility. “By working with Cellares, we are evaluating how automation can strengthen manufacturing reliability and scalability as we advance this program toward clinical development.”
“Gene-modified HSPC therapies are a natural fit for the Cell Shuttle and an area where Cellares has established manufacturing expertise,” said Fabian Gerlinghaus, Co-Founder and CEO of Cellares. “By automating complex workflows, including electroporation, we can deliver the scalability, reliability and manufacturing economics required to advance these therapies through clinical development. This partnership extends that capability to SNUH as it prepares its PNH program for future clinical development in the United States.”
Gene-modified HSC manufacturing remains labor-intensive, variable and difficult to scale, which can limit clinical development, increase manufacturing costs and constrain patient access. Cellares says the Cell Shuttle is designed to automate end-to-end cell therapy manufacturing and improve scalability and reliability for autologous cell therapy programs.