DS Production-Our Services

Drug Substance

With a strong track record of high batch success rates, Intellective Bio ensures superior product quality and safety, enabling a seamless transition from clinical to commercial manufacturing. Our drug substance production facilities are equipped with bioreactors ranging from 200 L to 6,000 L, available in both single-use and stainless-steel configurations to flexibly meet various production needs across different scales and stages.

  • Suzhou Changshu Site (Headquarters)
  • Suzhou Industrial Park Site
  • Suzhou Xiangcheng Site
  • DS7
    DS8
    DS11
    DS12
    DS15(ADC)
    DS16

    DS7 is equipped with two DS production lines, each featuring four 6,000-liters stainless steel bioreactors as its core highlight, and offers a flexibly adjustable production scale ranging from 2,000 liters to 6,000 liters. Through the organic integration of a Distributed Control System (DCS), a process monitoring and data acquisition system (SCADA), the production lines achieve a high level of automated monitoring and control.

    26.7 kL
    ×4
    6,000 L Stainless steel
    ×1
    2,000 L Single Use System
    ×1
    200 L Single Use System
    Production Capacity : 103 kL
    Batch Success Rate : 99%

    Intellective Bio has configured a 2,000-liter single-use bioreactor (SUS) production line, which is specially designed to meet the production needs of both clinical-stage and commercial-scale manufacturing. Compared with the 6,000-liter stainless steel production line, this line offers higher flexibility and turnaround efficiency, and can quickly adapt to the production arrangements of multiple projects and product varieties.

    6.7 kL
    ×3
    2,000 L Single Use System
    ×2
    500 L Single Use System
    ×1
    200 L Single Use System
    Production Capacity : 103 kL
    Batch Success Rate : 99%

    DS11 further enhance the company’s DS manufacturing capacity and accelerate the R&D and production processes of diverse biopharmaceuticals for global clients. Equipped with two DS production lines, this module enables flexible manufacturing at scales ranging from 2,000 L to 6,000 L, fully meeting clients’ end-to-end needs from clinical development to commercial production.

    24 kL
    ×4
    6,000 L Stainless steel
    Production Capacity : 103 kL
    Batch Success Rate : 99%

    Compared with the Phase I production line design, the Phase II design features significant improvements in automation level and energy conservation. In terms of production control, the entire line adopts stainless steel bioreactors and is equipped with an integrated DeltaV automation control platform. The production line incorporates a black-white zoning design and a heat recovery system, achieving over 30% energy savings.

    24 kL
    ×4
    6,000 L Stainless steel
    Production Capacity : 103 kL
    Batch Success Rate : 99%

    DS15 is a conjugation production workshop with a maximum single-batch production capacity of 500 liters (5–10 kg protein). It can achieve an annual output of up to 1,000 kg of ADC drug substance, providing clients with flexible production solutions ranging from laboratory-scale trials to commercial manufacturing .

    In the purification stage, a single-use ultrafiltration system is adopted, where all product-contacting components are single-use assemblies, thus minimizing the risk of cross-contamination to the greatest extent.

    Production Capacity : 103 kL
    Batch Success Rate : 99%

    DS16 is a pilot-scale production workshop designed to provide clients with a bridging platform spanning from process development to clinical sample preparation, facilitating the smooth transition of products from laboratory-scale research to commercial manufacturing.

    It allows flexible adjustment of production scales according to project phases and process requirements, and supports the manufacturing of various types of antibodies and recombinant proteins.With its scalable process configurations and flexible equipment combinations, DS16 not only meets clients’ requirements for process verification and optimization, but also provides reliable technical support and data accumulation for future commercial manufacturing.

    24 kL
    ×3
    200 L Single Use System
    ×1
    500 L Single Use System
    ×1
    500 L Stainless steel
    Production Capacity : 103 kL
    Batch Success Rate : 99%
  • DS4
    DS5

    The facility is equipped with three seed bank liquid nitrogen tanks and eight Cytiva single-use bioreactors with working volumes of 200 L and 2,000 L, supported by Cytiva chromatography systems, Millipore/Pall/Cobetter depth filtration platforms, as well as large-scale continuous centrifugation. Our production workshops strictly comply with domestic and international GMP standards to ensure high-quality and highly consistent manufacturing .

    4.4 kL
    ×2
    200 L Single Use System
    ×2
    2,000 L Single Use System
    Production Capacity: 103 kL
    Batch Success Rate : 99%

    Intellective Bio offers robust and comprehensive manufacturing capabilities with ample PCB, MCB, and WCB storage supported by advanced vapor-phase liquid nitrogen tanks equipped with automated supply and filling functions.

    6 kL
    ×3
    2,000 L Single Use System
    Production Capacity: 103 kL
    Batch Success Rate : 99%
  • DS2
    DS3

    Intellective Bio operates an advanced fed-batch drug substance production line, integrated with Cytiva chromatography systems and depth filtration platforms from Millipore/Pall/Cobetter.

    2.7 kL
    ×1
    200 L Single Use System
    ×3
    500 L Single Use System
    ×1
    2,000 L Single Use System
    Production Capacity : 103 kL
    Batch success rate : 99%

    With ample PCB, MCB, and WCB storage supported by state-of-the-art Danfoss vapor-phase liquid nitrogen tanks featuring automated supply and filling functions, our large-scale production facilities strictly comply with domestic and international GMP standards.

    0.2 kL
    ×1
    200 L Single Use System
    Production Capacity: 103 kL
    Batch success rate : 99%
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