Intellective Bio's Operational Production Capacity Surpasses 100,000 Litres-Newsroom

Lines 9 and 10 of Intellective Bio (Suzhou) Co., Ltd. are scheduled to commence operations in September 2025. This expansion will significantly increase Intellective Bio's drug substance capacity, accelerating and empowering global innovative pharmaceutical companies in the R&D process of diverse biologics.

The previously commissioned Lines 7 and 8 in 2023 comprise two cell-culture lines and two protein-purification lines. With production scales ranging from 2000 litres to 6000 litres, they offer flexible configuration to meet clients' full-process requirements.

Founded in 2018, Intellective Bio established its multi-module, integrated biologics production site in Changshu in 2021, which became fully operational in 2023. With the new lines coming online, the total capacity will be substantially elevated to 103,300 litres. The newly commissioned lines possess an annual production capability of 2,500 kilograms of antibody-based drugs, theoretically sufficient to meet the clinical medication needs of approximately 500,000 patient treatments. The product portfolio covers large-molecule drugs including monoclonal antibodies, bispecific antibodies, fusion proteins, Antibody-Drug Conjugates (ADCs), and vaccines, with a strategic focus on therapeutic areas such as oncology, autoimmune diseases, and metabolic disorders.

Core Highlights

Green & Intelligent Design

• The newly launched production lines feature a black-white zoning design, reducing cleanroom volume by 71% and air-conditioning energy consumption by 35%, embodying the philosophy of green manufacturing.

• Equipped with a high-efficiency heat recovery system, steam consumption for hot-water units is reduced by 30%, promoting highly efficient energy recycling within the facility.

Integrated Safety & Intelligence for Excellent Operations

• The Changshu site utilises an automated material handling system, enabling precise sample delivery from multiple production lines to the IPC testing centre within 30 seconds. This minimises transfer risks and ensures data timeliness.

• The Emerson DeltaV™ Distributed Control System serves as the automation platform for drug substance production, enabling "centralised monitoring and decentralised control" of upstream and downstream processes. It facilitates independent process control, ensuring that anomalies in a single unit operation do not impact overall production, thereby greatly enhancing system reliability and safety and enabling intelligent production management.

• The implementation of an online buffer preparation system (CIP/SIP) allows for automatic and precise buffer preparation according to preset recipes, with real-time on-demand replenishment. This significantly saves storage space, reduces manual intervention and handling risks, and improves overall production efficiency and batch-to-batch consistency.