The production of biopharmaceuticals, particularly antibody drugs, has long been hindered by complex manufacturing processes and heavy reliance on imported equipment and key materials. The approval of China’s first 10,000L biosimilar production line marks a significant leap in the nation’s capacity for large-scale biopharmaceutical industrialization, establishing a new benchmark for the commercial-scale production of biosimilars.

As a strategic partner of Chia Tai Tianqing, Alioth has been deeply involved in optimizing the deep filtration process of this production line. By deploying its cutting-edge Alidep^® Depth Filter technology, Alioth has supported the client throughout the entire journey—from process validation to commercial production—ensuring stable and efficient operations.

In large-scale biosimilar production, deep filtration is a critical step for ensuring product safety and quality. Leveraging its proprietary Alidep^® Depth Filter technology, Alioth has delivered:

• Customized Filtration Solutions: Tailored membrane material selection and flow rate optimization to meet the demands of large-scale production, ensuring efficient removal of impurities.
• Process Stability Assurance: A rigorously validated filter production system to guarantee batch-to-batch consistency and minimize risks in large-scale manufacturing.
• Localization Breakthrough: Cost-effective solutions to reduce dependence on imported products, helping clients achieve cost savings and operational efficiency.

From laboratory research to commercialization, and from technological innovation to industrial application, Alioth remains committed to its mission of “creating value for clients” by addressing their production challenges. Looking ahead, Alioth will continue to advance its expertise in bioprocessing technologies, collaborating with industry partners to contribute to China’s pharmaceutical innovation and global competitiveness.

The Alioth Alidep^® depth filter is primarily used for the clarification step in pharmaceutical processes, offering greater flexibility for large-scale production with its disposable design.

The Alidep^® Depth Filter features various media combinations, mainly composed of cellulose, filter aids, and positively charged resins. It provides strong dirt-holding capacity and is suitable for clarifying cell culture fluid. It can progressively retain intact cells and cell fragments, reduce turbidity, and effectively absorb impurities such as DNA, HCP, and endotoxins, thereby reducing the pressure on subsequent purification steps.

Different product specifications are available to meet the needs of laboratory, pilot-scale, and production-scale applications.

Typical Applications

• Clarification of CHO cell culture fluid

• Clarification in vaccine production process

• Clarification of yeast fermentation broth (after centrifugation)

• Clarification in plasmid production process (E. coli lysate)

• Clarification of lentivirus and adeno-associated virus culture fluid