CytoNiche has a 3D cell large-scale preparation process development platform that meets GMP standards. Based on our unique degradable microcarrier technology and 3D cell preparation process, a fully automated production line for cell drugs and their derivatives has been established. It subverts the traditional artificial cell production and preparation process, and realizes large-scale, automated, standardized and intelligent production and preparation of cell drugs and their derivatives, significantly reducing the production costs of cell drugs and their derivatives, as well as the quality differences between different batches of cells. On this basis, we provide CDMO services that are significantly different from the existing CGT cell preparation process, with technical research, process development and GMP production services including large-scale production and preparation as well as process development of mesenchymal stem cells (MSC), exosomes and viruses from different tissue sources to facilitate product transformation and clinical application from innovative achievements.

Stem Cell Clinical Study Project Filing (Non-IND) - Pharmaceutical Studies

Preclinical Studies of Stem Cell Drug and IND Application (IND) - Pharmaceutical Studies

Pre-IND Supporting Services

• Preparation of cell quality validation materials for National Institutes for Food and Drug Control (or a third-party organization with CNAS certification)
• The certificate of analysis issued by the National Institutes for Food and Drug Control (or a third-party organization with CNAS certification) after validation of quality of three batches of stem cell preparations
• Design of protocol for pharmacology and toxicology studies (drug efficacy and safety) which are preclinical studies of stem cells and communication with third-party CRO companies
• Writing of preclinical pharmaceutical research data, and preclinical pharmacology and toxicology data
• Preparation of filing materials for clinical study projects of stem cells
• Preparation of IND application materials for stem cell drugs
• Design of protocol for 3D intelligent production cell preparation workshop that meets the requirements for clinical and commercialized registration.
• Selection, performance confirmation and verification of cell production and quality testing equipment and facilities

Advantages of CDMO Service for 3D FloTrix^® Cell Large-Scale Intelligent Production

• The core products, 3D TableTrix^® Microcarriers (Tablet) and 3D FloTrix^® bioreactor, are independently developed and certified by national patents
• 3D TableTrix^® Microcarriers (Tablet) is made of pharmaceutical-grade raw materials, with the qualification for pharmaceutical excipients from the National Medical Products Administration (registration number: F20200000496, F20210000003) and the qualification of pharmaceutical excipients filed by the U.S. FDA/DMF (DMF: 35481)
• The 3D FloTrix^® process is designed for customized, large-scale, intelligent and standardized production and preparation (production scale: 500mL-15L)
• Follow the continuous and closed production process specified in "Guideline for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Draft for Solicitation of Opinions)"
• The human umbilical cord mesenchymal stem cells prepared by the large-scale expansion process of 3D TableTrix^® Microcarriers (Tablet) have been tested for cell quality compliance in the National Institutes for Food and Drug Control
• Compared with traditional artificial 2D cell culture, it can save about 90% of space, 90% of labor force, 60% of reagents and consumables and 60% of time cost
• Cell workshops that meet the registered clinical and commercialization requirements: Full B+A, unidirectional flow, Full-GMP

• Beizheng Biotech entrusts CytoNiche to conduct preclinical studies of "3D TableTrix^® Microcarrier Expansion hAMSCs Therapeutic Drugs"

• Tuohong, SAFE, CANVEST

The R&D team of CytoNiche is committed to providing the overall solution of 3D microcarrier-based large-scale customized cell expansion process and solving problems encountered in the upstream process development of gene and cell therapies, extracellular vesicles, vaccines and proteins.
 
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