Fast-Tracking Development of MSC-Based Cell and Extracellular Vesicle Therapies Through a Strategic Partnership

The therapeutic potential of mesenchymal stem cells (MSCs), particularly for the regenerative medicine space, has generated significant attention in clinical research. These cells, which can be derived from bone marrow, adipose tissue, or the umbilical cord among others, are isolated and cultured and have been shown to restore cellular function and repair injured tissue across a range of disease states. They are also one of the more encouraging sources for exosomes which hold promise in supplanting traditional nanocarriers for drug and gene delivery.

Yet, just as with many of the novel modalities being explored in the cell therapy space, MSC development is accompanied by several challenges related to adequate characterization, regulatory adherence, and balancing upstream and downstream development considerations. As developers work to scale MSCs and MSC-EVs, the value of identifying a contract development and manufacturing organization (CDMO) with the incumbent expertise, capacity, and supporting partnerships to fast-track these crucial modalities is key to advancing their therapeutic potential and regulatory acceptance.

Addressing Complexity and Accelerating Development: RoosterBio and FUJIFILM Diosynth Biotechnologies

For many cell therapy companies the ability to focus their expertise on the foundational clinical science surrounding an MSC asset versus the complexity of their manufacture is crucial to the development of these therapeutics. Having manufacturing partners with specialized and complementary expertise in process development, cGMP manufacturing, including scale up, and quality control standards of MSCs and EVs can be key to achieving the timely delivery of these lifesaving medicines to the patient. Vetting a potential CDMO partner for more novel cell therapy modalities like MSC-based and EV therapeutics often requires an evaluation of an organization’s experience with both relevant technologies and related advanced therapies. Likewise, evaluating the CDMO’s partnering capability, particularly when it comes to establishing an end-to-end development and commercialization paradigm, can help close the loop to secure the expertise necessary for seamless scale-up.

To achieve this accelerated development, FUJIFILM Diosynth Biotechnologies and RoosterBio have partnered to link optimized process development and analytical workflows via seamless technology transfer to scale up and cGMP manufacturing. RoosterBio, a leading supplier of technology for biomanufacturing of MSCs and MSC-exosomes, has established an interconnected and comprehensive portfolio of products that spans cell sourcing, culture media, isolation technology, and banking services, as well as raw materials, media, gene editing technologies, and analytical assays. This specialization, when combined with FUJIFILM Diosynth Biotechnologies’ global advanced therapy manufacturing network and full-service preclinical-to-commercial capabilities, has served to establish a workflow optimized for these highly bespoke, highly valuable therapeutics.

Through its extensive process and analytical experience, RoosterBio offers:

• Quality, well-defined raw materials (cGMP cells and media backed by FDA Type II Master Files)
• Optimized, scalable processes
• Experienced teams in MSC and MSC-EV product, process, and analytical development
• Consistent CMC-compliant protocols (with “CMC-ready” documentation available)

Through its long-standing tech transfer and GMP manufacturing experience, FUJIFILM Diosynth Biotechnologies offers:

• 30+ years’ experience in cGMP manufacture
• Skilled teams in dedicated workflows
• Quality track record
• End-to-end capabilities

RoosterBio can do much more than provide raw materials to its clients – its capabilities span process and analytical development to offer companies as much support as necessary to optimize their clinical asset. Likewise, FUJIFILM Diosynth Biotechnologies has positioned itself to work with both RoosterBio and its clients collaboratively to ensure that the tech transfer process and subsequent scale-up are performed as efficiently and cost effectively as possible. This starts with achieving familiarity with RoosterBio’s established processes via transfer of the technology and extends to facility fit for each individual client process. Along the way changes to equipment and consumable materials are evaluated to consider supply chain, forecasting, and scale.

A Streamlined Partnership for Quality and Risk Mitigation

Advancing MSC-based cell therapy products into clinical trials requires highly specialized process and analytical development as well as expertise in cGMP manufacturing. Through its collaboration with RoosterBio, FUJIFILM Diosynth Biotechnologies’ aim is to achieve greater efficiencies in scaling these unique therapeutics and for collaborative innovation in an emerging and evolving space. FUJIFILM Diosynth Biotechnologies has leveraged unit operations from decades of experience in biologics and advanced therapies to produce MSCs and MSC-based EV products. Its global quality system is also well-suited to MSC production, and its project management experience, which spans cell-based therapies, engineered tissues, EVs, and cell-based gene therapies, is well-positioned to offer the flexibility and speed necessary to accelerate MSC product development and commercialization.

CDMO PARTNER FOR LIFE

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