RoosterBio and Secretome Therapeutics Celebrate Milestone in Large-Scale Cell Therapy Production
Major Milestone in Cell Therapy Production
In a groundbreaking collaboration, RoosterBio Inc. and Secretome Therapeutics have successfully concluded the large-scale production of a pivotal cell therapy candidate, STM-01. This significant achievement took place on October 6, 2025, and sets a new standard for scalable solutions in the field of regenerative medicine.
Overview of the Collaboration
RoosterBio, known for their expertise in stem cell technologies, partnered with Secretome Therapeutics, a clinical-stage biotechnology firm focused on developing innovative therapies from neonatal cardiac progenitor cells (nCPC). The aim was to enhance the manufacturing process for STM-01, which is currently undergoing phase I clinical trials aimed at treating heart failure with preserved ejection fraction (HFpEF) and dilated cardiomyopathy (DCM).
In March 2025, the collaboration was initiated with RoosterBio establishing a 50-liter cGMP-compliant bioreactor system for producing STM-01, transitioning from a less efficient 2D flask-based method. This advanced bioreactor technology represents a substantial increase in production capabilities, allowing for greater efficiency and scalability, critical factors in moving therapies from the lab to the clinic.
Significant Achievements
RoosterBio's development program included crucial stages such as media comparability and optimization studies conducted using Ambr®250 microscale bioreactors. Following successful tests in 3L bioreactors, a full-scale run in a 50L bioreactor was achieved. This milestone was celebrated by both companies as they transferred the process to Secretome’s contract manufacturer for immediate implementation.
A vital component of this production process is RoosterBio's specially designed cGMP-grade cell expansion medium, prcRoosterNourish™-MSC-CC, alongside the bioreactor feed prcRoosterReplenish™-MSC-CC. This fed-batch media system is tailored for enhanced efficiency and cost-effectiveness, making it possible to produce innovative therapies like STM-01 with greater ease.
Leadership Insights
Tim Kelly, CEO of RoosterBio, expressed enthusiasm about the partnership, noting, “We’re thrilled to partner with the amazing team at Secretome Therapeutics, a true innovator in the field of cell and secretome therapy.” He emphasized the value of RoosterBio’s twelve years of product and process development experience in achieving scalable production of important therapies.
Vinny Jindal, President and CEO of Secretome, also highlighted that scaling up stem cell therapeutics has historically presented challenges to FDA approval, making manufacturing a core focus since the company’s inception three years ago. This successful collaboration marks a significant hurdle overcome on the path to making effective heart therapies more accessible.
Future Directions
The partnership between RoosterBio and Secretome extends beyond STM-01, with commitments to advancing further projects, including the lead preclinical asset STM-21. This innovative therapy leverages the secretome from STM-01 and is being studied for its usability in treating neurological conditions, such as amyotrophic lateral sclerosis (ALS) and diabetic neuropathy, as well as for managing inflammatory skin conditions.
Company Background
RoosterBio has established itself as a leader in developing human mesenchymal stem/stromal cell products and bioprocess development, aiming to facilitate rapid and cost-effective clinical implementations. Their high-quality MSCs, coupled with extensive expertise in bioprocessing, help therapeutic developers transition efficiently from concept to human testing.
Meanwhile, Secretome Therapeutics is at the forefront of creating innovative regenerative therapies that focus on harnessing the healing power of bioactive factors secreted by cells. This pioneering approach looks to meet significant medical needs while advancing the field toward off-the-shelf biologic solutions.
Conclusion
The recent success of RoosterBio and Secretome in scaling up the production of STM-01 marks a major advancement not just for the companies involved, but for the future of cell-based therapies in treating critical health issues like heart failure. This collaboration exemplifies how innovative partnerships can drive transformative health solutions, creating a promising pathway for future therapeutic advancements.
Topics Health）
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