Upgrade of Chromatography Resin Manufacturing Site in Lanzhou, Empowering Safe, Efficient, and Sustainable Biopharmaceutical Separation and Purification Technology
On June 30, 2023, the commissioning ceremony of the Bio-Link Chromatographic Chromatography Resin Manufacturing Site Phase II was successfully held in Lanzhou, Gansu Province, China. Since its establishment, Bio-Link has been dedicated to the research, development, and manufacturing of key process equipment and consumables for recombinant protein drugs, vaccines, antibody drugs, cell therapies, gene therapies, and other biopharmaceutical products. The product range covers upstream bioprocess cell culture, disposable liquid handling and downstream processes such as chromatography, ultrafiltration, and filtration units, as well as process development services.
In the field of chromatography media, Bio-Link previously established a production base (Phase I) in Lanzhou. The base comprises two chromatographic packing production lines of 500L and 1000L respectively, a well-equipped quality inspection laboratory, and has been certified by ISO9001:2015. In terms of technology, the base offers a variety of chromatographic packing products including dextran-based matrices, agarose-based matrices, and hydroxyapatite matrices. These products cover six principles of chromatography: gel filtration chromatography, ion exchange column chromatography, hydrophobic exchange chromatography, affinity chromatography, multimodal chromatography, and reversed-phase chromatography. The total production capacity of the phase I site is 40,000 liters per year. As of May 2023, the Phase I base has produced over 100 types of chromatographic packing products, with a cumulative production volume exceeding 30,000 liters. It has undergone more than 50 customer site audit certifications, and achieved 482 batches of safe production.
Preparations for the Phase II of the Bio-Link Chromatographic Packing Intelligent Manufacturing Base in Lanzhou began in September 2021. In order to differentiate from the Phase I base, which relied more on manual operation and control, the Phase II base embraced the challenge of upgrading to "intelligent manufacturing". With no ready-made domestic cases to reference, over the past two years, the Phase II base has made steady progress, optimizing and enhancing production line equipment and processes. It has achieved 85%-90% automated control and process management, effectively avoiding potential product quality fluctuations caused by manual operation.
Furthermore, the Phase II base is designed in accordance with the ESG principles of energy efficiency, high efficiency, and environmental friendliness, with a Class A explosion-proof plant of over 3,000 square meters, effectively solving the compliance challenges of safe production. The introduction of automation control systems such as DCS and GDS will also ensure the stability and safety of production, to realize the real "intelligent manufacturing plant". With such support, Bio-Link will achieve a total production capacity of 120,000 liters per year. Whether in terms of automation or capacity expansion, Bio-Link's Chromatography Resin Manufacturing Site Phase II in Lanzhou is leading the industry.
The biopharmaceutical industry requires advanced technologies and the development of a more robust upstream and downstream ecosystem. With a vision of "Link to enable biotherapeutics" Bio-Link is dedicated to providing the biopharmaceutical industry with comprehensive bioprocessing solutions with high quality, easy verification, cost-effectiveness, and a secure supply chain.