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Cell therapy and regenerative medicine applications have the promise to change and save lives. With the rapid advancements across the cellular therapy field, many different cell types and platforms are now in use to develop future therapeutic treatments for today’s diseases.
To realize these therapies, it’s critical to plan for tomorrow. Therapeutic research must be focused on producing a consistent, safe, and effective cell product, regardless of the research stage or cell type used. All research programs must consider the complexities in manufacturing, regulatory, testing, delivery, and ultimately patient use at every step of the process.
This article discusses four key factors researchers should consider when selecting a supplier in cell therapy research to include risk assessment, raw materials, regulatory requirements, and scale-up potential.
It’s no secret that product discontinuations or even delays in product availability ultimately presents major challenges to therapeutic research efforts and process development. Partnering with a reliable and transparent supplier who has years of experience working alongside emerging companies helps in the long-term success of the company. Conducting risk assessments of your program and suppliers is a critical factor to consider in any program.
Captivate Bio offers lot reservation programs, reagent sourcing services, and custom media services for those in the pre-clinical stage of therapeutic discovery. Services include prototyping, custom formulations, as well as sourcing ancillary materials for clinical research. Off-the-shelf products include serum-free media, salt solutions, human platelet lysate, small molecules, proteins and cytokines, matrices and substrates, and premium FBS including MSC-qualified is also available upon request.
Management of raw materials is critical to ensuring the streamlined development and production of cell-based therapies. The sensitivity and biological nature of cell therapy products is highly impacted by the quality of raw materials used, including the cell starting material, cell culture environment, and other processing components. As the development of a cell-based therapy progresses, so does the dependence on the quality and specific raw materials used in protocols, as variability or changes in raw materials can significantly alter the efficacy and/or safety of the final product. Reserve key raw materials in advance to ensure product and supply continuity. Contact Captivate Bio today to learn how we can help support your program with our lot reservation and storage programs.
Regulatory governance for ancillary materials (raw materials) used in cell-based therapies must be adhered to and should be incorporated into research workflows as early as possible. Ensure that all culture system parameters and formulations in the development process are animal origin free, with strenuous performance and quality testing. Choose a raw material supplier that will provide materials produced using cGMP practices in dedicated ISO-certified facilities, and who will provide regulatory guidance and support for the products as ancillary materials.
Identify opportunities for automation and process streamlining as early in the development process as possible to improve efficiency and reduce variability in manufacturing. Incremental optimization at a smaller scale will reduce the cost and risks associated with optimization at a large scale. Ensure early on that culture systems are amenable to scale and optimization, while developing reliable and thorough protocols to ensure reproducibility both over time and across production sites. With a global network of partners, Captivate Bio can help offer guidance on manufacturing and materials for your program.
Delays or changes in raw material accessibility or changes to the product’s quality, performance, or regulatory conformation ultimately present a high risk to therapeutic commercialization and process development. Partnering with a reliable and transparent supplier for raw materials in cell culture development is critical to the development process and ultimately the long-term success of the therapy. Choose a supplier who is experienced, resourceful, transparent, and committed to the success of your therapy product at every step of the way.
Learn more about how we support researchers with cell culture products, contract manufacturing and storage services, custom reagent sourcing, as well as marketing, sales, and distribution programs for our industry partners.
Agile and aspirational - in this interview, Captivate Bio’s Lori Oakes discusses navigating the road to commercialization and providing insight on successful customer support strategies.
Captivate Bio has become the go-to supplier for premium FBS and specialty serum solutions. Request a sample to evaluate today.
December 2021 - Captivate Bio, a scientific supplier of cell culture reagents and services, announced it has expanded its leadership team with the appointment of Lia Thornberry Kent as its Director of Technology.
