The 3D microcarriers independently developed by Huakan Biotechnology, "Gelatin Microcarrier" and "Gelatin Microcarrier for Cell Use", were registered and approved by the Drug Evaluation Center (CDE) of the National Drug Administration on December 7, 2020 and February 24, 2021 (registration numbers: F20200000496 and F202100003), respectively. This product is the first pharmaceutical microcarrier in China that can be used for cell drug development.

Complete 1 FDA DMF filing for pharmaceutical excipients

On April 15, 2021, according to the official website of the FDA in the United States, CytoNICHE completed the qualification filing for DMF pharmaceutical excipients (DMF: 035481), which is the first domestic "Gelatin Microcarrier TABLET FOR CELLS, STERILE, EXCEPIENT" used for cell drug production and regeneration therapy. It is also a microcarrier product in the DMF filing list published on the FDA website in the United States.

In July , 2023, Cytoniche Bioscience's core research product, 3D TableTrix® Microcarriers, successfully obtained FDA Type II Drug Master File (DMF) registration with the filing number 037798. 

This latest FDA DMF Type II registration signifies that Cytoniche Bioscience's 3D TableTrix® Microcarriers can not only serve as essential pharmaceutical excipients but can also be used as active pharmaceutical ingredients (APIs), becoming a major component in drug formulations. They can play a pharmacological role or other direct effects in the diagnosis, treatment, mitigation, prevention, or impact on the structure and function of the human body, among other applications.

Microcarrier products completed 1 FDA-MF qualification filing

In July 7, 2023, following the acquisition of DMF Type II & IV qualifications, Cytoniche Bioscience's 3D TableTrix® Microcarriers have once again obtained the 【MF qualification registration】 issued by the Center for Biologics Evaluation and Research (CBER) under the U.S. Food and Drug Administration (FDA), with the registration number MF 29721.

This FDA CBER registration signifies recognition of Cytoniche Bioscience's microcarrier quality control and production capabilities. It indicates that Cytoniche Bioscience's 3D TableTrix® Microcarriers have met more refined and targeted international standards and regulatory requirements for biologics, making them stable and reliable for use in vaccine and biologics production.

In June 2023, Cytoniche Bioscience's original research product, 3D FloTrix® Serum-Free Culture Medium for Mesenchymal Stem Cells, obtained Drug Master File (DMF) registration with the U.S. Food and Drug Administration (FDA) with the DMF registration number 038476.

The significance and importance of DMF registration lie in providing a reliable platform for pharmaceutical companies to demonstrate the quality and safety of their products to regulatory authorities. It also provides regulatory agencies with a means to oversee and review pharmaceuticals.

Obtaining DMF registration is another important qualification achieved for 3D FloTrix® Serum-Free Culture Medium for Mesenchymal Stem Cells, confirming that Cytoniche Bioscience's production process and quality control system have met international standards and regulatory requirements.

CytoNiche's 3D Microcarrier Fully Enclosed Scalable Preparation of Umbilical Cord Mesenchymal Stem Cells Obtains Certification from the China National Institutes for Food and Drug Control (NIFDC)!

On September 6, 2023, a medical institution serviced by CytoNiche's CDMO platform submitted samples for inspection. The institution utilized CytoNiche's three-dimensional cell cultivation process (3D TableTrix® microcarriers + comprehensive 3D FloTrix® vivaSPIN bioreactor) for the fully enclosed scalable preparation of umbilical cord mesenchymal stem cells. After undergoing quality review by the China National Institutes for Food and Drug Control (NIFDC), these cells officially received the "Inspection Report" (Number: SH202311161). This achievement marks the first instance in China where mesenchymal stem cells cultured on 3D microcarriers have been verified for quality through the NIFDC. (Previously, CytoNiche's 3D TableTrix® microcarriers had also undergone NIFDC's quality and safety assessments.)

On September 7, 2023, CytoNiche commissioned by a CDMO client, sent umbilical cord mesenchymal stem cells prepared using CytoNiche's 3D FloTrix® Hundred Billion Process to Wuhan JiaChuang Biological Technology Co., Ltd. for quality review. They officially received the "Test Report" (Number: Inspection Letter <2023>012302052) issued by the third party. This marks the first instance in China where umbilical cord mesenchymal stem cells, prepared through a continuous and closed production process, capable of producing billions in a single batch, have undergone third-party quality review.

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.