The ribbon-cutting ceremony of the new Class B clean factory of Beike Biotech Shenzhen Regional Cell Preparation Center was grandly held

Posted on 2022-10-27
12:00 am

On October 26, 2022, the ribbon-cutting ceremony for the 2022 important project of Shenzhen Beike Biotechnology Co., Ltd. “Shenzhen (Beike) Regional Cell Preparation Center New Class B Clean Factory” was held grandly. Hu Junyuan, Chairman of Beike Biotech, Liu Xiangyang, Senior Vice President of Beike Biotech, and Liu Shikang, CEO of Shenzhen Alpha Biomedical Technology Co., Ltd., cut the ribbon for the new Class B clean factory.

font-family: "Source Sans Pro", Arial, Tahoma, sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgb(98, 98, 98); letter-spacing: 1px; text-wrap: wrap; background-color: rgb(252, 252, 252);”>

It is reported that,This project was invested and constructed by Beike Biotech Headquarters, and it is a high-standard, standardized clean factory that was constructed, accepted and used in strict accordance with GMP clean grade B standards. At the same time, this project is also a construction project that strictly followed the relevant government regulations for housing and construction bureau, environmental impact assessment, and fire protection registration, and successfully passed the acceptance inspection. At present, the new clean workshop (including related auxiliary functional areas) has been completed and put into use.

According to the requirements of Good Manufacturing Practice (GMP), the cleanliness level of the factory is divided into four levels: A, B, C, and D. The requirements for suspended particles between level C and level B are 100 times different! Due to factors such as high economic costs and complex and strict control processes, currently the vast majority of domestic enterprises that use non-fully enclosed cell production and preparation processes use Class C clean plants, and few companies use Class B plants. As a major upgrade of Beike Biotech’s cell preparation and production facilities, the new clean plant fully complies with Class B standards and meets the production requirements for “sterile drugs” and “biological products” in the 2010 version of Good Manufacturing Practice (GMP) and the necessary conditions for the “Good Manufacturing Practice for Stem Cell Preparation Preparation” certification of the China Medical Biotechnology Association. It has promoted the smooth implementation of multiple clinical research projects of Beike Biotechnology.

Dr. Hu Junyuan, chairman of Beike Biotechnology, said at the ribbon-cutting ceremony that factory facilities are a vital part of the cell preparation and production process. Only by effectively controlling the production environment and continuously improving the level of hardware facilities can we promote the development of cell products to a higher quality level while continuously and stably outputting safe and effective cell products. The design and construction of the new factory integrates process applicability, advanced facilities, energy conservation and environmental protection, and factory safety. It is a high-end professional hardware and software benchmark project in the industry carefully created by Beike Biotech. The putting into use of the Class B factory is evidence that Beike Biotech uses actions to interpret its product and service awareness. Only by continuously improving its own technical level can we meet customers’ intrinsic needs for added value of products and implement our common grand vision – to be a leading company in promoting the clinical transformation of biotherapeutic technologies and make unremitting efforts to improve human health!