Downstream Solution
Downstream Processing Solutions
Advanced downstream processing equipment and engineering solutions for the biopharmaceutical industry. GMP-compliant systems include:
- Process chromatography and in-line conditioning
- Ultrafiltration, filtration, and virus removal
- Bulk dispensing and automated buffer preparation
Innovative solutions such as continuous chromatography, automated ADC, and alkaline lysis systems, trusted by leading life science companies.
Inline Conditioning Process Chromatography System (ICPC)
Improved productivity:
- Faster processing times and higher throughput, ultimately leading to increased production capacity.
Reduced costs:
- Fast buffer stabilization time making it a more economical option for large-scale production.
Enhanced process control:
- Provide real-time monitoring and control of the chromatography process. This ensures consistent product quality and minimizes the risk of product contamination or deviation from desired specifications.
Flexibility and scalability:
- Can be easily integrated into existing bioprocessing facilities, allowing for seamless scalability and flexibility. They can be adapted to various process formats, including batch, fed-batch, and continuous modes.
Simplified operation:
- User-friendly interfaces and automation capabilities, simplifying operation, minimizes the potential for human errors, improving overall process reliability.
Reduced footprint
- Compact designs, requiring less physical space compared to traditional chromatography setups.
Manual Screw-Driven Axial Compression Column
- Materials meeting the requirements for biopharmaceutical production processes.
- Movable top adapter.
- Easy to operate, easy to maintain, net pore size: 20μm (10μm optional).
- Hygienic design complying with cGMP requirements.
Electrical Motor Driven Axial Compression Columns
(EAC-Bio)
- Designed for cGMP production. Contact Materials comply with FDA/USP Class VI requirements.
- Hygienic design, Clean-in-place.
- Applicable to many different resins.
- Patented distribute plate design ensuring even flow distribution through the column.
- Transparent acrylic column tube, with rotatable design to make column cleaning and maintenance convenient.
- Reproducible packing operated from the packing station.
- IQ/OQ documentation support customization available provided.
Dynamic Compression Column with precision control
Columns are the core of industrial buffer preparation chromatography separations. During the operation of DAC, the piston can provide continuous pressure to ensure the density and stability of the packed column bed, so as to maintain the best separation effect for a long time. The column efficiency and service life are much higher than that of conventional chromatographic columns.
- Using advanced structure design, simple appearance, flexible and convenient operation.
- Using precision mechanical polishing technology to minimize the tube wall effect during packing and using.
- High column efficiency and good asymmetry: For 10µm C18 packing material, the column efficiency can reach more than 40000N/m, and the asymmetry can be 0.9-1.2.
- Customized design services for products with special requirements is provided.
Single-Use Ultrafiltration System
- Four specifications are optional: 0.5m2, 5m 2, 10m2, 20m2.
- Circulating pump: peristaltic pump and disposable PP diaphragm pump head are optional.
- Clamping holder PP material
- Disposable consumables, sterilization by Radiation.
- Supporting integration with mixer.
Fully Automated Ultrafiltration TFF System
Filtration Type & Process Applications
- The filtration type can be selected flexibly according to different processes, which can adapt to the different kind of hollow fiber cartridge and flat membrane cassette, to realize ultrafiltration, concentration, buffer exchange or clarification microfil-tration process.
Control Strategy & Operating Modes
- The control strategy includes various control modes such as constant TMP, constant Fr, constant △P and fixed pump speed, covering the need for most ultrafiltration processes. Other special control strategy can be customized.
Automation Software & Control Platforms
- Ultrafiltration software can be based on different platforms, such as DCS (Delta V or PCS 7) or PLC control (WinCC or Lab Windows). All control platforms meet the requirements of FDA 21 CFR Part 11 electronic signature, electronic record and audit trail requirements.
Inline Integrity Testing System
- The system includes an inline integrity test module, which can complete the integrity test without disassembling the membrane cassettes/cartridge, based on brands, models, and membrane areas. Test result can be saved in the batch report.
Water Flux Testing Function
- The system can perform inline water flux test function, and save the result in the batch report.
System Customization & Plant Integration
- The system can be fully customized according to the plant layout and the process train to meet the customer’s need.
Membrane Area & System Capacity
- 0.1—0.5m² , 0.5—3 m², 0.5—5 m², 5-20 m², 20-40 m², 40-60 m² and up to 300 m²
HPHS Hygienic Slurry Tank
- Designed for media slurry storage, buffer exchange of the media, and stirring of the slurry during column packing of large-scale chromatography.
- Movable skid design for easy use and maintenance.
- Low shear gentle stirring to ensure uniform resin slurry.
- Tank material: 316L stainless steel.
- Sizes up to 5,000L
Buffer Storage Container
High compatibility:
- Adapt to most of the buffer storage bag in the market.
Comprehensive functionality:
- Removable type pH, Cond, temperature probe and sampling port, which can dock to plant refrigerant/TCU.
- Equipped with Loadcell and magnetic levitation agitator.
Ergonomic design:
- Fully optimized space and personnel requirements.
Expansibility:
- Ability to dock to OS station of DCS/Stand-alone operation.
Beautiful Exterior:
- Surface sandblasting treatment.
Laboratory-scale fully automated chromatography system
- The integrated design of pumps, valves and detectors are simple and applicable, and various configurations are suitable for both basic and complex advanced applications.
- The interface of the software workstation is simple and easy to operate, and it is equipped with the verification function that meets the requirements of FDA 21 CFR Part II.
- New type collector, with high speed and stability.
Alkaline Lysis System (pDNA extraction) /Tubular Hold Vessel For Continuous Processing
- The first domestically developed Escherichia coil online alkaline lysis system, which is applied to large scale and sanitary preparation of super coiled plasmid DNA. It solved the problem of scale-up production of Escherichia coli alkali lysis, and improved the plasmid recovery rate greatly while maintaining the plasmid configuration.
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