Beike Biological Preparation Center
The latest process research results in 2024
Internationally renowned journals in the field of stem cells
Published in “Stem Cell Research & Therapy”!
On May 3, 2024, Chu Wanglong’s team at the preparation center of Shenzhen Beike Biotechnology Co., Ltd. published an important research paper in the internationally renowned journal “Stem Cell Research & Therapy” in the field of stem cell research [1]. The paper is titled “A GMP-compliant manufacturing method for Wharton’s jelly-derived mesenchymal stromal cells”, with an impact factor of 7.5, ranking Q1 in the JCR Division, and is also a top journal in Region 2 of the Chinese Academy of Sciences.
In recent years, a large number of studies have shown that umbilical cord mesenchymal stem cells have broad application prospects in the field of regenerative medicine, and their powerful immune regulation and tissue repair capabilities have attracted much attention. Compared with bone marrow mesenchymal stem cells, umbilical cord mesenchymal stem cells are more convenient to obtain and can significantly reduce the pain and ethical controversy during the collection process. In addition, the unique low immunogenicity and high proliferation ability of umbilical cord mesenchymal stem cells make them ideal for large-scale expansion. More importantly, long-term in vitro culture has little impact on its phenotypic and genetic stability, which adds important weight to its broad potential in clinical applications.
Relevant guidelines [2] issued by the National Medical Products Administration clearly state that the concept of “quality by design” should be followed when developing cell-based drugs. The complexity of cell products far exceeds that of ordinary drugs. Their production not only requires the quality of the cells themselves, but also requires in-depth research and strict control of the production process, as well as full verification of the applicability of the detection methods.
In this study, the team emphasized the importance of establishing Good Manufacturing Practice (GMP) compliance standards. First, ensure that all selected materials meet GMP or pharmaceutical grade standards, then optimize key process parameters and smoothly expand to cell factory systems. At the same time, comprehensive quality control and stability studies are conducted, including cell morphology observation, cell number and viability testing, cell expansion ability analysis, cell phenotype testing, growth curve and cell cycle analysis, colony formation ability testing, cell senescence analysis, multi-directional differentiation potential testing, karyotype analysis, biological efficacy testing (immune regulatory ability testing) and microbial control to ensure the production of high-quality WJ-MSCs. By developing simplified and innovative methods to isolate and culture WJ-MSCs, the team not only increased cell yield but also ensured cell viability, growth potential, purity, and functionality throughout the production process. These works ultimately ensure the production of safe and effective WJ-MSCs. (Part of the results of the paper are shown in Figure 1-2)
(Figure 1 Partial results of process research)
(Figure 2 process amplification part results)
At the same time, the paper mentioned that the cell production and quality control in the research were completed in Beike Biotech’s GMP standard factory. An innovative production process was used in the research. After detailed process exploration, stable batches of cell preparations were produced. The safety and effectiveness testing of the cells met the quality standards, which marked that Beike Biotech’s cell preparation capabilities have reached the industry-leading level. Recently, Beike Biotech successfully developed China’s first new stem cell drug for systemic lupus erythematosus, which has been approved for clinical trials, further proving that Beike’s cell production process and quality meet pharmaceutical standards.
The strength of a company’s scientific research team is an important indicator of a company’s scientific research capabilities, and it also reflects the company’s investment and commitment to scientific research. Companies that can invest a lot of time, energy and money in research and development, promote the transformation of technological achievements, overcome “stuck” problems, and master key core technologies are the industry leaders that truly use technological innovation as the engine of development.
Beike Biotechnology, which has been deeply involved in the cell field for 18 years, has always regarded R&D and innovation as the core driving force for the company’s development. The latest research results highlight its outstanding capabilities in cell preparation and detection. The preparation center team’s capabilities in process development, scale-up and comprehensive quality studies have been widely praised by authoritative journals in the field of stem cells. Beike Biotech adheres to its customer-centered service concept and continues to make new progress in process improvement, quality control and compliance with GMP standards to ensure that the cell products it produces are both safe and of high quality. In the future, Beike Biotech will continue to adhere to the vision of “promoting the clinical transformation of biotechnology and making unremitting efforts to improve human health” and contribute more to the development of the cell industry.