RoosterBio Helping Secretome Therapeutics Scale Cardiac Cell Therapy Manufacturing
RoosterBio and Secretome advance scalable cell therapy manufacturing with a new 50L bioreactor process for STM-01 clinical trials.
RoosterBio and Secretome Therapeutics have completed commercial-scale production of Secretome’s lead neonatal cardiac progenitor cell (nCPC) therapy, STM-01. This milestone follows the initiation of a development services program in March 2025 to establish a 50-liter (L), cGMP-compatible bioreactor-based manufacturing process for STM-01, which is currently in Phase I clinical trials for heart failure with preserved ejection fraction (HFpEF) and dilated cardiomyopathy (DCM).
The new 50L bioreactor process is designed to replace Secretome’s previous 2D flask-based method. RoosterBio’s process development included media comparability studies, optimization using Ambr®250 microscale bioreactors, and confirmation in 3L systems before moving to full-scale production. The completed 50L run is now being transferred to Secretome’s contract manufacturer for immediate use.
A critical component of this process is the use of RoosterBio’s cGMP-grade cell expansion medium (prcRoosterNourish™-MSC-CC) and its paired bioreactor feed (prcRoosterReplenish™-MSC-CC).
“We’re thrilled to partner with the amazing team at Secretome Therapeutics, a true innovator in the field of cell and secretome therapy,” stated Tim Kelly, CEO of RoosterBio. “RoosterBio has spent the last twelve years developing the products and biomanufacturing processes necessary to achieve scalable, cost-effective production of cell and exosome therapeutics. It’s extremely gratifying to be part of the team making transformative therapies like STM-01 more accessible to patients suffering from heart failure.”
“Historically, the scale-up of stem cell-based therapeutics has represented a hurdle towards FDA approval, making manufacturing a top area of focus for Secretome since its founding 3 years ago,” said Vinny Jindal, President and CEO of Secretome. “The RoosterBio team’s world-class experience scaling up production of mesenchymal stem cells enabled us to reach this major milestone, and we look forward to working with them on STM-03 and our other pipeline products.”
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