As dendritic cells (DCs) are increasingly applied in research for human diseases, the validation of DCs in vitro has become a critical need. With over 10 years of experience in cell-based therapy development, Creative Biolabs has established a comprehensive platform to provide high-quality DC-based therapy services including validation of DCs.
Dendritic cells (DCs) are increasingly prepared in vitro for use in the experimental immunotherapy of human diseases, particularly cancer and autoimmune diseases. The production of DCs with optimal immunostimulatory properties and their exploitation in immunotherapy necessitated an understanding of the biology of these cells during in vitro culture. Therefore, various protocols for the culture of these cells were established with the specific purpose of human clinical use, and various advantages ascribed to each. Recent improvements in DC manufacture include the use of serum-free media, the use of IL-13 (instead of IL-4) in concert with GM-CSF, or other cytokine combinations, the development of fully closed purification and culture systems, and novel DC maturation methods suitable for clinical application. In light of such developments and the probability that different methods will produce distinct DCs with varying characteristics or heterogeneous populations, a critical need has emerged for the quality control of ex vivo manufactured DCs.
Assay validation provides an assurance that a test method is reliable for its intended purpose. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines detail the parameters and characteristics that must be considered during validation of analytical assays that are used to determine responses of clinical trials. The in vitro immunogenicity risk assessment assays are currently positioned as internal risk management tools, generally used as screening assays to assist product design and candidate selection during the early stage of product development.
For preclinical toxicology and clinical studies, validation of DCs not only need to assess the morphological and functional quality of each batch of these cells but also be able to monitor the stability of these cells upon long-term cryostorage. Quality control is generally achieved by phenotypic and functional testing of DCs. The mixed lymphocyte reaction (MLR) assay has served as the gold standard for evaluating the functional ability of antigen-presenting cells. Immunophenotyping by flow cytometric methods, which is been used to determine the purity of DC preparations, has also been used as a surrogate of potency.
Committed to cell-based therapy development for more than 10 years, Creative Biolabs is the professional in the validation of DC-based therapy for autoimmune diseases. With the comprehensive platform we established based on over 10 years of practice, we are confident in providing high-quality validation services.
With great confidence from practice, Creative Biolabs has met hundreds of researchers' requirements and thus established a good industrial reputation. If you have any requirements about the validation of DCs or have any other questions about our services, please feel free to contact us for more information.
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especially in antibody and cell therapy for autoimmune diseases.
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