The Business of Biofabrication

Cellino, a Cambridge-based biotech innovator specializing in autonomous biomanufacturing, has announced a strategic partnership with Karis Bio, a South Korean leader in cell therapy, to drive forward a groundbreaking autologous induced pluripotent stem cell (iPSC)-derived therapy for cardiovascular disease. This collaboration not only marks Cellino’s expansion into the Asia-Pacific market but also represents a pivotal step toward industrializing personalized regenerative treatments for conditions like peripheral artery disease (PAD) and coronary artery disease (CAD).

Who Are the Companies?

Cellino
Based in Cambridge, Massachusetts, Cellino is at the forefront of biomanufacturing innovation. Its Nebula™ platform integrates AI-driven automation, robotics, and high-throughput processing to produce high-quality, patient-specific iPSCs. These induced pluripotent stem cells can be reprogrammed from a patient’s own cells, offering a personalized therapeutic option with minimized risk of immune rejection. The Nebula™ system is a closed, autonomous manufacturing platform designed to operate at the point of care, ensuring consistency and scalability in the production of complex cell therapies.

Karis Bio
Headquartered in Seoul, South Korea, with a U.S. base in Atlanta, Karis Bio is a clinical-stage biotechnology company focusing on regenerative therapies for cardiovascular diseases. Their core innovation lies in autologous iPSC-derived endothelial cell (iPSC-EC) therapy, designed to stimulate the formation of new blood vessels in patients suffering from PAD and CAD. By leveraging patient-specific cells, Karis Bio’s approach offers a regenerative alternative to invasive procedures like stenting or bypass surgery, while avoiding immune-related complications.

Why Is This Partnership Valuable?

1. Pioneering Personalized Cardiovascular Therapies
   This collaboration aims to industrialize the world’s first clinical-stage autologous iPSC-derived therapy for PAD and CAD. Karis Bio has already launched a first-in-human clinical trial in South Korea, using patient-specific iPSCs to regenerate damaged blood vessels and restore circulation in ischemic tissues. By integrating Cellino’s Nebula™ platform, Karis Bio can scale up its manufacturing processes to meet clinical and future commercial demands.
2. Manufacturing at Scale with AI and Robotics
   Cellino’s Nebula™ platform addresses one of regenerative medicine’s greatest challenges: manufacturing complex, patient-specific cells reliably and at scale. Its closed-cassette design ensures contamination-free, reproducible production, reducing human error and variability. For Karis Bio, this technology accelerates the move from clinical research into broader clinical trials and eventual commercialization, especially for autologous therapies, which require individualized cell lines for each patient.
3. Expanding Global Access
   The partnership supports Cellino’s inaugural expansion into the Asia-Pacific region, signaling the company’s intent to globalize access to personalized regenerative therapies. The collaboration will initially focus on scaling production in South Korea but has plans to expand into U.S.-based Phase 2 trials via Karis Bio’s Atlanta operations. This cross-continental strategy strengthens regulatory pathways and market reach for both companies.
4. Addressing a Critical Medical Need
   PAD and CAD affect millions globally, leading to restricted blood flow, tissue damage, and increased risk of heart attacks and amputations. Karis Bio’s regenerative approach harnesses the body’s own healing potential, offering a less invasive, patient-specific solution with the potential for long-term restoration of vascular function.

A Step Toward the Future of Regenerative Medicine

The partnership between Cellino and Karis Bio exemplifies how biomanufacturing innovation and cellular therapy breakthroughs can converge to advance personalized medicine. Together, they aim to reshape how cardiovascular diseases are treated, making therapies that were once experimental into accessible solutions for patients worldwide.

Original article here.