RoosterBio Partners with MineBio to Expand MSC and Exosome Manufacturing Solutions in China
核心洞察
RoosterBio (搜索) has formed an exclusive distribution partnership with MineBio Life Sciences (搜索) to bring cGMP-grade MSC and exosome bioprocessing media to China's rapidly growing regenerative medicine sector.
The partnership addresses China's position as a global leader in MSC and exosome clinical research, with one of the highest concentrations of active trials worldwide.
MineBio has already secured import approval for RoosterBio (搜索)'s research-grade and CliniControl (搜索)™ cGMP media platforms, enabling immediate order fulfillment without regulatory delays.
RoosterBio (搜索), Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs) and advanced therapy manufacturing solutions, has announced an exclusive distributor partnership with MineBio Life Sciences (搜索) Limited to expand access to scalable MSC and exosome bioprocessing solutions throughout China. The partnership delivers RoosterBio's research-grade and CliniControl (搜索)™ cGMP media platforms to China's cell and gene therapy developers, with MineBio holding critical import approval for immediate order fulfillment.
Strategic Response to China's Growing Regenerative Medicine Market
The partnership addresses China's emergence as a global leader in MSC and exosome clinical research. According to Tim Kelly, CEO of RoosterBio (搜索), "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." The country'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.
Kelly emphasized the strategic importance of finding the right partner for market entry: "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."
Comprehensive Manufacturing Platform
RoosterBio (搜索)'s CliniControl (搜索)™ product line encompasses 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 platform has demonstrated 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. According to RoosterBio (搜索), the company has enabled therapeutic programs to traverse their path to clinical translation in under one year.
Regulatory Compliance and Market Access
A critical advantage of the partnership is MineBio's pre-secured import approval for RoosterBio (搜索)'s research use only and cGMP CliniControl (搜索)™ MSC and exosome bioprocessing media platform, enabling orders to be fulfilled without delay. Amy Zuo, General Manager of MineBio Life Sciences (搜索), highlighted the comprehensive nature of the offering: "RoosterBio delivers far more than just cGMP media; they provide a complete, built-in biomanufacturing platform."
Zuo emphasized the regulatory compliance capabilities: "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." The partnership aims to empower Chinese developers to confidently accelerate their dual US-China and global IND pipelines.
Market Positioning and Implementation
MineBio Life Sciences (搜索), a Shanghai-based distributor specializing in cell and gene therapy, stem cell, and regenerative medicine sectors, brings established relationships and expert guidance across China's advanced therapy landscape. As a subsidiary of LabDirect China Limited (搜索), MineBio leverages its parent company's supply chain infrastructure and expertise in importing high-risk biological products.
The partnership positions both companies to serve developers at all stages of therapeutic development. MineBio's portfolio supports customers across the full product development continuum, including research-grade to cGMP-quality culture matrices, transfection reagents, viral transduction systems, and specialized biologics manufacturing inputs.
MineBio began accepting and fulfilling RoosterBio (搜索) orders immediately following the partnership announcement, providing Chinese developers with direct access to globally recognized, Master File-backed products integrated with extensive CGT supply chain and technical expertise.