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Research Innovation

Product Qualification

CytoNiche

Successfully filed for 2 qualifications for pharmaceutical excipients from CDE

The 3D microcarriers independently developed by CytoNiche—"Gelatin Microcarrier" and "Gelatin Microcarrier Tablet for Cells", were evaluated to successfully qualify for pharmaceutical excipient by the Center for Drug Evaluation of the National Medical Products Administration on December 7, 2020 and February 24, 2021, respectively (registration number: F20200000496, F20210000003) and were approved. The product is the first domestic pharmaceutical microcarrier that is applicable for the cell drug development.

Completed the filing of 1 DMF qualification for pharmaceutical excipients from US FDA

(https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs), "Gelatin Microcarrier Tablet for Cells", the first domestic product for the production and preparation of cell therapy and regeneration therapy, completed the filing of the DMF qualification for pharmaceutical excipients (DMF: 35481). It is also the only microcarrier product in the DMF filing list announced on the official website of the US FDA.

CytoNiche

Scientific and Technological Achievements

  • 62

    number

    Applied for 62 Chinese patents

  • 5

    number

    Applied for 5 international patents

  • 2

    Sum

    Completed the filing of 2 qualifications for pharmaceutical excipients from CDE

  • 1

    Sum

    Completed the filing of 1 DMF qualification for pharmaceutical excipients from US FDA

  • 2

    Sum

    Completed the filing of 2 qualifications for first-class medical devices

  • 30

    Piece

    Published more than 30 SCI articles

  • 1

    Sum

    Selected in 1 project of the Zhongguancun Subversive Technology Research and Development and Achievement Transformation

Certified by the intellectual property management system

Certified by the ISO9001 quality management system

Certified by the ISO13495 medical device quality management system

Quality and Safety

完成2项CDE药用辅料备案

Certified by the ISO9001 quality management system and ISO13495 medical device quality management system

CytoNiche adheres to the concept of providing customers with high-quality products and attaches great importance to product quality. The design and construction of the manufacturing platform comply with the relevant regulations of the GMP and ISO.The quality management system follows the GMP and ISO standards, and thus avoiding the contamination, errors, and confusion in the process to the greatest extent, and ensuring the safety and effectiveness of products.

Safety Evaluation by the National Institutes for Food and Drug Control and Jiangsu Center for Safety Evaluation of Drugs

For the microcarrier materials and lysis buffer of CytoNiche, a series of safety evaluation experiments have been completed by the third-party institutions (National Institutes for Food and Drug Control, Jiangsu Center for Safety Evaluation of Drugs), and summary reports have been formulated.On this basis, CytoNiche has worked with the National Institutes for Food and Drug Control to establish the testing methods and standards for detecting the specific amino acids in raw microcarrier materials and the residues with enzyme activities in the lysis buffer.

完成1项FDA药用辅料DMF备案
完成1项FDA药用辅料DMF备案

News about Innovation

Industry Trend | CDE Publicly Solicits Opinions on "Guideline for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Draft for Solicitation of Opinions)"
2021 08-17

Industry Trend | CDE Publicly Solicits Opinions on "Guideline for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Draft for Solicitation of Opinions)"

On August 17, the Center for Drug Evaluation of the National Medical Products Administration issued a notice to solicit public opinions on the "Guideline for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Draft for Solicitation of Opinions)".
Cutting-Edge Research | 3D Microcarrier as a Delivery Tool to Assist Gene-Modified Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes
2021 07-09

Cutting-Edge Research | 3D Microcarrier as a Delivery Tool to Assist Gene-Modified Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes

Type 2 diabetes (T2DM) is one of the most serious chronic diseases that threaten human life and health. The main clinical manifestations are insulin resistance and depletion of pancreatic islet functions. Traditional T2DM drugs are difficult to restore blood glucose back to normal in some patients, and may cause various adverse reactions such as hypoglycemia, diarrhea, nausea, and vomiting.
AHM 细胞微球组装与3D打印结合的新策略
2020 10-09

AHM 细胞微球组装与3D打印结合的新策略

大尺度复杂组织的体外构建存在着包括高活性的细胞扩增,大尺度结构的快速、精确制备,以及合适的细胞微环境等挑战。清华大学医学院的杜亚楠课题组近期在Advanced Healthcare Materials期刊上发表了“TGase‐Enhanced Microtissue Assembly in 3D‐Printed‐Template‐Scaffold (3D‐MAPS) for Large Tissu
Copyright: Beijing CytoNiche Biotechnology Co., Ltd.
Copyright: Beijing CytoNiche Biotechnology Co., Ltd.