On January 13, 2025, Chengdu Yousainuo Biotechnology Co., LTD. (hereinafter referred to as: Chengdu Yusanuo announced that its independently developed CD19-targeted chimeric antigen receptor (CAR) allogeneic universal T-cell injection (UC101) has received approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial application (IND). This is also the first universal CAR-T product in China to pass the FDA's new drug clinical trial application.
Baorui Biology extends its warmest congratulations to its partners on this significant progress!
Baorui Biology"Mycoplasma DNA Detection Kit" After comprehensive methodological verification, it has the advantages of simple operation, rapid detection, high sensitivity, good specificity and strong applicability. The production process and quality control system comply with the requirements of regulatory application, which can effectively assist in the rapid application of new drugs.
Regarding cord blood allogeneic universal CAR-T
UC101 is the world's first allogeneic CAR-T derived from umbilical cord blood to receive FDA IND approval. T cells derived from umbilical cord blood are the youngest T cells and have the natural advantages of low immunogenicity and being in an early differentiated state. The low immunogenicity of umbilical cord blood T cells can reduce the host anti-graft (HvGR) response, making allogeneic universal CAR-T easier and better to expand in patients and significantly increasing the median survival time of allogeneic CAR-T cells in vivo. More importantly, 90% of the T cells in umbilical cord blood are naive T cells. After large-scale expansion in vitro, there are still 80% of Tscm and Tcm cells. The Tscm and Tcm cells in the early stage of differentiation have stronger in vivo expansion ability and persistence, which makes the product have better therapeutic effects。
About ChengduYousenuo
Chengdu Yousainuo Biotechnology Co., Ltd. was established in 2020, dedicated to the research and development and industrialization of allogeneic universal CAR-T cell therapy drugs.
The early platform technology of Chengdu Yousenuo demonstrated significant efficacy and good safety in the IIT clinical trials of acute B-lymphoblastic leukemia (B-ALL). The latest platform technology has expanded the IIT clinical trial research to multiple indications such as multiple myeloma (MM), systemic lupus erythematosus (SLE), and Sjogren's syndrome (SjD). In the IIT trial for systemic lupus erythematosus, significant expansion of CAR-T cells and reconstruction of B cells have been achieved in multiple consecutive patients. The autoreactive antibodies of the patients have significantly decreased and are expected to achieve drug-free remission, which is comparable to the international industry data of autologous CAR-T. Yousenuo is committed to providing a wider range of patients with more cost-effective treatment options, improving their quality of life and restoring their confidence in life.
Mycoplasma DNA Detection Kit
货号: BP-QN08-50、BP-QN22-50
The traditional method for detecting mycoplasma requires at least 28 days of cultivation to reach a conclusion, which is quite time-consuming. The EP guidelines point out that if the sensitivity of the NAT detection protocol can reach the same level as the classical culture method and it has good robustness and specificity, then the NAT method can be used as a mycoplasma detection protocol to replace the classical culture method. The qPCR kit offers a very rapid and easy-to-use solution for mycoplasma control in laboratories or on production lines.
FastDetectionThe detection time is short, and the entire detection can be completed in as fast as 1.5 hours.
OperationSimpleSingle-tube PCR reagents: The extracted nucleic acids can be directly added to the PCR reaction solution without the need for multiple components to be mixed. 2μL of the sample can also be taken for direct amplification.
Internal standardSystemIntroduce internal quality control (internal standards) and positive quality control (PC) to effectively prevent the occurrence of false negative and false positive results. Improve the quality of testing.
ExclusiveGood sexThe optimized TaqMan probe covers more than 200 mycoplasma 16S rRNA genes and has high specificity. More than 30 structural analogues of mycoplasma and commonly used cell lines were verified, and none of them had cross-reactions with mycoplasma detection reagents.
Gao LingSensitivityThe detection limit reaches 5CFU/mL, fully complying with the requirements of EP 2.6.7 regulation.
ApplicableStrong performanceCompatible with multiple PCR instruments, no new equipment is required. Multiple types of matrix samples were verified, and different sample matrices had no effect on the detection sensitivity, especially suitable for high-concentration cell samples.
Anti-pollutionThe UDG enzyme anti-contamination system is adopted to effectively prevent contamination of amplification products.
MajorPerformance verification is carried out strictly in accordance with the provisions of the pharmacopoeia, and a complete set of performance evaluation materials can be provided.
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