On 26 October 2022, Shenzhen Beike Biotechnology Co., Ltd.'s key 2022 project, the "new Class B clean facility at the Shenzhen (Beike) Regional Cell Preparation Center", held a grand ribbon-cutting ceremony. Dr. 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 together for the new Class B clean facility.
The project, invested in and built by Beike Biotech's headquarters, is a high-standard, well-regulated clean facility built, accepted and used in strict accordance with GMP Class B clean standards. The project also strictly followed relevant government regulations for filings with the Housing and Construction Bureau, environmental impact assessment and fire safety, and successfully passed each of these reviews. The new clean facility (including related auxiliary functional areas) is now fully completed and in operation.
Under the requirements of Good Manufacturing Practice (GMP) for drugs, clean facilities are classified into four grades: A, B, C and D. The requirements for airborne particles in Class C versus Class B differ by a factor of 100! Considering the high economic cost and the complex, stringent control procedures, the vast majority of domestic enterprises and institutions using non-fully-closed cell production processes adopt Class C clean facilities, with very few opting for Class B. As a major upgrade to Beike Biotech's cell preparation production facilities, the new clean facility fully meets Class B standards and satisfies the necessary conditions for "sterile drugs" and "biologics" production set out in the 2010 edition of the Good Manufacturing Practice for Drugs (GMP) and required by the China Medicinal Biotech Association's "Good Manufacturing Practice for Stem Cell Preparations" certification, supporting the smooth implementation of multiple Beike Biotech clinical research projects.
At the ribbon-cutting ceremony, Dr. Hu Junyuan, Chairman of Beike Biotech, said that production facilities are a critical part of the cell preparation process. Only by genuinely controlling the production environment and continuously raising the level of hardware can we drive cell products toward higher quality while continuously and reliably delivering safe and effective products. The design and construction of the new facility integrate process applicability, advanced facilities, energy efficiency and environmental protection, and facility safety – it is a benchmark high-end professional hardware-and-software project carefully crafted by Beike Biotech. The commissioning of the Class B facility is concrete proof of Beike Biotech's commitment to product service: only by continuously raising our own technical level can we meet customers' inherent demand for product value-add, and only thus can we live up to our shared grand vision – becoming a leading enterprise driving the clinical translation of biotherapeutic technologies and tirelessly working to improve human health!
