Cellares, a pioneer in integrated cell therapy manufacturing, has announced a strategic collaboration with Seoul National University Hospital (SNUH) to revolutionize the production of gene-modified hematopoietic stem and progenitor cell (HSPC) therapies. The partnership aims to transition SNUH’s specialized therapy for paroxysmal nocturnal hemoglobinuria (PNH) from manual, labor-intensive methods to an automated, scalable framework powered by Cellares’ proprietary Cell Shuttle platform.
Paroxysmal nocturnal hemoglobinuria is a rare, life-threatening blood disorder. While gene-modified HSPC therapies offer transformative potential for patients, the current manufacturing landscape for these treatments is fraught with challenges. Traditionally, the production process is highly variable, difficult to scale, and requires significant manual intervention. These constraints not only increase manufacturing costs but can also create bottlenecks that hinder clinical development and limit patient access to potentially life-saving interventions.
The proof-of-concept collaboration will center on the successful technology transfer of SNUH’s unique manufacturing process to the Cell Shuttle. This initiative will specifically utilize the Cell Shuttle’s fully integrated, single-use electroporation module to facilitate a sophisticated two-step transfection workflow. By digitizing and automating these complex steps, the partners expect to establish a robust, closed-system manufacturing strategy that meets the stringent requirements for clinical-grade production.
This agreement marks a significant milestone for Cellares, representing its second major partnership in Asia and further solidifying its growing footprint in the Asia-Pacific biotech ecosystem. The primary objective of this joint effort is to support preclinical development and IND-enabling manufacturing, laying the groundwork for SNUH to eventually bring its PNH therapy into clinical trials within the United States.
“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.”
For Cellares, the partnership underscores the versatility of the Cell Shuttle platform. While the system has already demonstrated success in autologous cell therapy programs, this collaboration highlights its ability to address the specific needs of gene-modified HSPC workflows.
“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.”
As SNUH and Cellares move forward, the success of this collaboration could set a new industry benchmark for the industrialization of cell therapies, ultimately providing a blueprint for how academic institutions and technology developers can work together to lower barriers to patient care.
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