[Background]

[About CBER]

CBER is a center under the authority of the FDA (a leading global regulatory agency for pharmaceuticals), with a primary focus on regulating biologic products intended for human use. While medical products are required to be safe, safety does not imply zero risk. All medical products are associated with some level of risk, and safe biologic products are those that possess reasonable risk. When choosing to use biologic products, a balance between the benefits gained and potential risks must be maintained. CBER's mission is to ensure the maximization of benefits and minimization of risks for patients through a scientifically rigorous product approval process.

CBER rigorously evaluates scientific and clinical data submitted by manufacturers for new biologic products and new indications for approved products. Based on the risk-benefit profile for the target population and the intended use of the product, CBER determines whether the product meets its approval standards.

The FDA CBER qualification filing obtained this time is a recognition of CytoNiche Biotech's quality control and production capabilities for microcarriers. It signifies that CytoNiche Biotech's 3D TableTrix® Microcarrier has met more refined and targeted international standards and regulatory requirements for biologic products. It can now be stably and reliably applied to vaccine and biologic product production. During the product declaration and certification phases, it can provide pharmaceutical companies with authoritative evidence of product quality and safety to regulatory authorities, serving as a crucial means for regulatory supervision and drug review.

[CytoNiche's Contribution to Declaration]

For numerous pharmaceutical clients, utilizing CytoNiche Biotech's FDA-DMF filing number instead of providing detailed information about materials and excipients during the declaration process can:

▷ Reduce the time required for data preparation, review, and evaluation

▷ Significantly save approval costs and enhance efficiency,

▷ Shorten drug registration cycles and expedite clinical/launch applications.

[CytoNiche's Support Services]

 ▷ If you are conducting research related to projects using 3D TableTrix® Microcarrier and need to submit applications to the FDA such as Investigational New Drug (IND) or New Drug Application (NDA), you can contact the relevant sales department to apply. CytoNiche Biotech will provide you with an authorization letter that allows the FDA to directly review the technical content of the DMF involved during drug application review, helping to expedite the FDA review process.

▷ If you're interested in CytoNiche Biotech's 3D TableTrix® Microcarrier, you can also scan the code to apply for a trial.

【CytoNiche】

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.

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.