Cn
EN
Research
Platform
Platform Introduction
The eukaryotic drug substance production line adopts the Quality by Design (QbD) philosophy. Differences across projects and product varieties are taken into full consideration since conceptual design. It supports clinical and commercial manufacturing of biomolecules including mAbs, bsAbs and fusion proteins expressed in mammalian cells, in compliance with GMP requirements of NMPA, FDA and EMA.
The maximum single-batch culture scale is 2000L. The ATF perfusion process is available for 500L perfusion culture or N-1 perfusion high-density inoculation to enable continuous batch production.
Service
Process & Content
Service Process and Content
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Seed Revival01 -
Cell Culture02 -
Clarification Filtration03 -
Chromatography04 -
Viral Filtration05 -
Ultrafiltration Concentration06
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Step-wise Scale-up
50L Rocker → 250L/2000L SUB → 2500L Tank, enabling seamless transition from seed stage to large-scale production with a maximum annual capacity of 16 batches. -
Closed Transfer
Buffer and intermediate products are transferred via through-wall pipelines to reduce open operations and maintain a sterile environment. -
Intelligent Control
Key process equipment is remotely monitored with data acquisition and backup via SCADA and Emerson Delta V systems. -
Flexible Process with Controllable Cost
Single-use liquid preparation and storage systems ensure process flexibility, effectively control costs and eliminate the need for cleaning validation.
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Comprehensive Quality System
Compliant with GMP requirements of FDA, NMPA and EMA based on ICH Q10 and ICH Q7.
Platform
Highlights
平台亮点
近1000㎡符合cGMP要求的真核原液生产区域，满足50L、250L、500L及2000L等多规模原液生产，设计独立的C级细胞接种、D级反应器培养间及独立的上、下游生产区域，并将下游病毒灭活前和病毒灭活后区域分开。
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50L ROCKER -
250L SUB -
500L SUB -
2000L SUB
The process design incorporates fed-batch with gravimetric and bleeding interlock functions. Load cell, peristaltic pump and pressure sensor functions are integrated into the reactor control interface. ATF or TFF systems are applied for perfusion harvest, and customized process bags are available. Optional N-1 perfusion combined with N-stage high-density inoculation can improve protein expression yield.
Single-use solution preparation systems with flexible adjustable volumes. Imported testing equipment is deployed. Process equipment includes multi-size chromatography systems, automatic ultrafiltration and DF/VF systems, compatible with various holders and membrane cassettes.
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HiRes Automated Cell Counter -
Cedex Bio Biochemical Analyzer -
Shaker -
Depth Filtration -
Dual-Pump Chromatography System -
Viral Filtration System -
Ultrafiltration System -
Chromatography Column