Partnership Delivers RoosterBio’s Research-Grade and CliniControl™ cGMP Media Platforms to China’s Leading Cell and Gene Therapy Developers; MineBio Holds Import Approval for Immediate Order Fulfillment
RoosterBio, Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered bioprocess media, and advanced therapy manufacturing solutions for hMSCs and exosomes, today announced an exclusive distributor partnership with MineBio Life Sciences Limited (MineBio), a trusted partner to China’s biopharmaceutical and advanced therapy community. Under the agreement, MineBio will distribute RoosterBio’s full platform of research-grade and CliniControl™ cGMP-grade MSC and exosome bioprocessing media throughout China. Critically, MineBio has already secured import approval for the organization’s research use only and cGMP CliniControl™ MSC and exosome bioprocessing media platform, enabling orders to be fulfilled without delay.
“China has emerged as a global leader in MSC and exosome clinical research, with one of the highest concentrations of active trials anywhere in the world,” said Tim Kelly, CEO of RoosterBio. “We have long sought the right partner to bring our platform to this market — someone who is deeply embedded in the Chinese cell and gene therapy community and genuinely trusted by the developers working to bring these therapies to patients.
MineBio’s expertise, robust customer network, and commitment to quality make them the ideal collaborator to expand access to RoosterBio’s RUO and cGMP media solutions. We are thrilled to work together to help China’s innovators increase their productivity and move faster from the bench to the clinic.”
— Tim Kelly, CEO, RoosterBio
RoosterBio’s CliniControl™ product line includes cGMP-manufactured MSC expansion media, exosome collection media, bioreactor feeds, and genetic engineering media designed to support the full continuum of hMSC, secretome, and exosome / extracellular vesicle product development, from early research through cGMP manufacturing. These products are supported by industry leading quality and regulatory documentation, including FDA Type II Master Files and regulatory support dossiers for trials in other jurisdictions.
The organization’s platform has strong global adoption, supporting GMP manufacturing for numerous trials since 2019 while providing advanced therapy developers with the regulatory support and product consistency required for therapeutic development.
China’s regenerative medicine sector has experienced rapid growth, with Chinese institutions and biopharmaceutical companies conducting a significant and growing number of MSC and exosome clinical trials. MineBio’s established relationships and expert guidance across China’s cell and gene therapy, stem cell, and regenerative medicine sectors position it uniquely to deliver RoosterBio’s platform to developers at all stages.
“RoosterBio delivers far more than just cGMP media; they provide a complete, built-in biomanufacturing platform,” said Amy Zuo, General Manager, MineBio Life Sciences. “As a premier provider of GMP manufacturing materials, tools, and turnkey solutions for China’s CGT sector, MineBio knows our clients urgently need scalable systems that comply with stringent Chinese and international regulatory standards (including NMPA, FDA, and EMA), while radically reducing the total cost of ownership.
By integrating RoosterBio’s globally recognized, Master File-backed products with our extensive CGT supply chain and technical expertise, we empower Chinese developers to confidently accelerate their dual US-China and global IND pipelines. We are fully prepared to drive our customers’ clinical and commercial success from day one.”— Amy Zuo, General Manager, MineBio Life Sciences
MineBio will begin accepting and fulfilling RoosterBio orders immediately. For more information about RoosterBio’s products available through MineBio in China, please visit www.roosterbio.com or contact MineBio at info@mine-bio.com.
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