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New CDMO Model of CytoNiche Facilitates Commercialization of Cell Therapy Products

New CDMO Model of CytoNiche Facilitates Commercialization of Cell Therapy Products

  • Categories:Company News
  • Author:CytoNiche
  • Origin:CytoNiche
  • Time of issue:2022-12-08
  • Views:0

(Summary description)

New CDMO Model of CytoNiche Facilitates Commercialization of Cell Therapy Products

(Summary description)

  • Categories:Company News
  • Author:CytoNiche
  • Origin:CytoNiche
  • Time of issue:2022-12-08
  • Views:0

[Background Introduction]

Recent years have witnessed a spurt of progress in the global biologic drug market, with a growth rate significantly higher than that of the overall pharmaceutical market, especially in the field of cell and gene therapy (CGT). 

CGT CDMO (Contract Development Manufacture Organization), as the upstream of CGT pharmaceutical companies, can help cell therapy companies overcome many difficulties in R&D and production, while reducing costs, to improve the R&D efficiency and enhance the commercialization process.


[Pain Points in the Industry]

Nowadays, the domestic cell therapy products are faced with the following challenges at different levels from R&D to commercial production:

At present, domestic companies carrying out CDMO services related to stem cell drugs are still limited to the application of traditional two-dimensional culture methods for stem cell preparation process, and cell production capacity can only be expanded by increasing the number of culture flasks (horizontally) or by employing more layers of cell factories (vertically), which is costly in terms of manpower, time and space consumption. To make it worse, the cell quality varies greatly from batch to batch, which is difficult to meet the demand for GMP capacity expansion of cell therapy products.

Figure 1: Layout and Manual Operation of Cell Factory


[New CDMO Model of CytoNiche]

In response to the above-mentioned challenges, CytoNiche, based on its unique biodegradable microcarrier technology and its 3D cell preparation process, has set up the GMP-compliant cell preparation platform - 3D FloTrix® Cell Technology Platform, which solved a series of bottlenecks in clinical application and commercial production of cell therapy products at present.



Figure 2: Real Scene of CDMO Service Platform of CytoNiche

(I) 3D FloTrix® Cell Technology Platform

The characteristics of cell therapy products determine the complexity of process flow design and special requirements of the auxiliary system. Regarding the process layout and plant facilities of their production workshop, factors such as site selection, production varieties and batches, process, product R&D and production stage should be fully considered. Only reasonable and standard-compliant plant design can ensure the safety and legality of products.

CytoNiche 3D Intelligent Manufacturing and Regeneration Medicine Center - 3D FloTrix® Cell Technology Platform already has a complete GMP quality management system, covering production management, quality control and quality assurance, plants and facilities, materials and products, validation and verification, contract manufacturing and contract verification, product shipment and recall, as well as self-inspection, etc.

All production and quality control personnel have received systematic training and they carry out production, recording, and inspection in strict accordance with the requirements of the quality management system, thus realizing the traceability management of the whole production process and meeting the needs of pre-clinical CDMO process development and technical services for stem cell therapy products.

Figure 3: Division of Basic Functional Zones of CytoNiche 3D FloTrix® Cell Technology Platform

(II) Equipment and Consumables for 3D Cell Culture

Based on the core technology products, 3D TableTrix® Microcarrier, 3D FloTrix® Automated Series Bioreactor and Cell Harvesting System, and combined with 3D FloTrix® Dynamic Culture Process, CytoNiche can not only meet the demand for cell yield in the process of clinical application and commercialization of stem cell products, but also avoid the contamination risk caused by the open operation, and significantly reduce the cost of consumables, manpower and time in the process of cell production and preparation. In addition, harvesting a large number of cells at one time can better ensure the quality uniformity of the final products of cells, reduce differences across batches in the process of cell preparation, and ensure the quality and safety of cell therapy products.

Figure 4: CytoNiche 3D FloTrix® Series Products

(III) Stem Cell Therapy Products and Services

CDMO of stem cell therapy products of CytoNiche focuses on the pre-clinical research of mesenchymal stem cells (MSCs).

The business scope includes:

Isolation of MSCs from different tissue sources;

Cell bank establishment at all levels;

Process development and scale-up;

Analytical method development and quality study; and

Clinical sample production and release, and IND declaration, etc.

Ensure standard-compliant product preparation, quality verification, quality management, pre-clinical pharmacology and toxicology, clinical protocols and other processes so as to meet regulatory requirements.

Figure 5: [Customer’s Case] Quality Review and Inspection by the National Institutes for Food and Drug Control of Stem Cells Prepared by the Three-dimensional Process of CytoNiche

The services include:

Stem cell product development strategy based on the concept of Quality by Design (QbD);

CMC process for three-dimensional stem cell amplification, which is different from other two-dimensional cell preparation processes;

Establishment of cell quality analysis method and quality standards that conform to the requirements of stem cell clinical research and IND declaration;

Third-party quality review of stem cells;

Pre-clinical pharmaceutical research - CMC pharmaceutical research documents;

Pre-clinical pharmacological and toxicological researches;

Filing and IND application of stem cell clinical research; and

GMP production space design and determination, equipment and facility selection, and performance qualification.

(IV) Cellular Exosome Therapy Products and Services

The following challenges still exist in the clinical use of exosomes:

Exosomes, as biological agents, contain one or more active substances made from or extracted from biological cells. The cells are amplified by in vitro culture, and the number and type of exosomes secreted each time are different, which may lead to heterogeneity of cell products between different batches;

From the perspective of process development, the heterogeneity of exosome products is influenced by the cell preparation process, including cell culture modes and cell culture conditions, which will significantly influence the quality of exosome products; and

The separation and purification methods for exosomes have not yet developed into standardized methods suitable for the large-scale application of pharmaceutical preparations, which affects the repeatability of research results.

In response to the above challenges, CytoNiche can provide the following services:



CytoNiche 3D Intelligent Manufacturing and Regeneration Medicine Center - 3D FloTrix® Cell Technology Platform has assisted a number of stem cell pharmaceutical enterprises in establishing fully automated stem cell drug production lines to realize large-scale, automated, standardized, and intelligent production and preparation of stem cell drugs. Meanwhile, production costs of cell therapy drugs and cell quality differences across different batches are significantly reduced, process reproducibility and reliability are improved, and complete data traceability and continuous monitoring are allowed, enabling quality control to conform to industry regulations.

On this basis, CytoNiche provides CDMO services different from the existing CGT cell preparation processes, including technical research, process development and GMP production services that cover mesenchymal stem cells (MSCs) and exosomes from different tissue sources, to facilitate product transformation and clinical application of innovative achievements.


Beijing CytoNiche Biotechnology Co., Ltd. was established by the research team of Professor Du Yanan from Tsinghua University School of Medicine, and was jointly established by Tsinghua University through equity participation. The core technologies were derived from the transformation of scientific and technological achievements of Tsinghua University. CytoNiche focuses on building an original 3D cell "smart manufacturing" platform, as well as providing overall solutions for the 3D microcarrier-based customized cell amplification process.

CytoNiche's core product, 3D TableTrix® Microcarrier Tablet (Microcarrier), is an independent innovation and the first pharmaceutical excipient grade microcarrier that can be used for cell drug development. It has obtained the certificate of analysis from relevant authoritative institutions such as National Institutes for Food and Drug Control, and obtained 2 qualifications for pharmaceutical excipients from the National Medical Products Administration (CDE approval registration number: F20210000003, F20200000496). Moreover, the product has obtained the DMF qualification for pharmaceutical excipients from U.S. FDA (DMF: 35481). 

Products and services of CytoNiche can be widely used in the upstream process development of gene and cell therapy, extracellular vesicles, vaccines, and protein products. At the same time, it also has broad prospects for applications in the fields of regenerative medicine, organoids, and food technology (cell-cultured meat, etc.).

Our company has a R&D and transformation platform of 5,000 square meters, including a CDMO platform of more than 1,000 square meters, a GMP production platform of 4,000 square meters, and a new 1200 L microcarrier production line. The relevant technologies have obtained more than 100 patents and more than 30 articles about the technologies in international journals have been published. The core technology projects have obtained a number of national-level project support and applications.


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Copyright: Beijing CytoNiche Biotechnology Co., Ltd.
Copyright: Beijing CytoNiche Biotechnology Co., Ltd.