GMP Grade Protein Purification System

 

The Jiuling GMP Grade Protein Purification System is an integrated downstream processing platform engineered for the separation, purification, and concentration of biological products.
In biopharmaceutical manufacturing, maintaining product quality requires equipment with ultra-stable operation, consistent process performance, and strict sanitary design. By consolidating multiple processing steps into a single, cohesive skid, Jiuling helps manufacturers simplify equipment integration, enhance automated process control, and achieve highly reproducible purification performance.

 

 

Parameter	Specification
Product Type	GMP Grade Protein Purification System
Application	Protein purification, antibody purification, enzyme purification, biopharmaceutical downstream processing
Production Scale	Laboratory, pilot, commercial manufacturing
System Structure	Integrated purification skid system
Main Processes	Filtration, chromatography integration, UF/DF, concentration, buffer exchange
Product Contact Material	SS316L stainless steel or pharmaceutical-compatible materials
Piping Design	Sanitary piping system
Surface Finish	Pharmaceutical-grade surface treatment available
Control System	PLC-based control with HMI option
Operation Mode	Manual / semi-automatic / automatic
Cleaning Method	CIP compatible design available
Sterilization	SIP capability available depending on configuration
Connection Type	Sanitary clamp, flange, customized connections
Testing	Factory inspection before shipment
Documentation	Drawings, material certificates, testing records, operation manuals

 

 

Compliant Sanitary Design & Contamination Control
Built to meet strict FDA cGMP, EU GMP, and ASME BPE regulations. Featuring SS316L product contact materials, a sanitary piping configuration with low delta-ferrite, minimized dead legs, and smooth internal surface finishes (Ra≤0.4um, electropolished) to ensure reliable Clean-in-Place (CIP) and Steam-in-Place (SIP) efficiency.

Stable Process Performance & Maximum Recovery
Optimized fluid paths reduce shear stress on sensitive proteins, while automated loop controls minimize human error. This ensures consistent batch-to-batch reproducibility and maximizes your product recovery rate.

Integrated Skid Design
Consolidating separate unit operations into a single turnkey skid reduces system footprint, eliminates integration complexities, simplifies operation management, and dramatically shortens on-site installation and commissioning timelines.

Linear Process Scalability
Built for seamless tech transfer. Our systems guarantee consistent fluid dynamics across all sizes, allowing you to scale up smoothly from laboratory process development to pilot scale-up and long-term commercial manufacturing without re-validating your core process.

 

 

Commercial Pharmaceutical Manufacturing: Long-term downstream purification of bulk drug substances.
Biotechnology Companies: Flexible, high-recovery platforms for emerging therapeutic pipelines.
CDMO Manufacturing: Highly adaptable, multi-product skids capable of fast turnaround between different customer processes.
Research & Pilot Facilities: Benchtop or compact mobile units optimized for scale-up studies and process optimization.

 

 

Clarification & Filtration Module
Designed to remove suspended solids, whole cells, and cell debris to safeguard downstream steps.
Core Benefits: Protects expensive chromatography columns and ultrafiltration membranes, reduces fouling risks, and ensures stable, high-yield product recovery.
Available Technologies: Depth filtration, membrane filtration, and cartridge filtration systems.

Chromatography Integration Module
Engineered for high-resolution purification based on your target molecule's specific characteristics.
Supported Methodologies: Affinity chromatography, ion exchange chromatography (IEX), and hydrophobic interaction chromatography (HIC).
Core Benefits: Precise gradient control and multi-valve switching to ensure optimal purity and step-yield.

Ultrafiltration & Diafiltration (UF/DF) Module
Widely utilized for concentration, de-salting, and final formulation buffer exchange.
Core Benefits: Efficiently increases protein concentration, removes unwanted small molecules, and replaces process buffers with minimal shear stress.
Configuration: Custom-designed membrane areas, cross-flow channels, and automated transmembrane pressure (TMP) control based on your processing volume.

Advanced Control & Monitoring System
Equipped with high-precision instruments to monitor and record critical process parameters (CPPs) in real-time.
Monitored Parameters: Pressure, flow rate, temperature, pH, UV absorbance, conductivity, and processing time.
Automation Levels: Available in Manual Operation, Semi-Automatic Control, or fully automated PLC-based systems with HMI touchscreens.

 

 

Process Configuration: Fully customizable as standalone filtration units, UF/DF concentration skids, automated chromatography systems, or complete combined downstream skids.
Processing Capacity: Sized dynamically based on your target batch volume, titer, flow rate requirements, and facility footprint constraints.
Equipment Structure: Available in open skid-mounted layouts, compact modular enclosures, or fixed multi-room split installations.
Automation Level: Scalable from basic process monitoring to advanced automated recipes with 21 CFR Part 11 compliant data recording for electronic signatures and audit trails.

 

 

Process Requirement Evaluation: You share your product type, batch volume, flow rates, and facility constraints. Our engineers evaluate the data to design a tailored system concept.
System Design & Proposal: Jiuling prepares detailed technical configurations, a P&ID layout, and a comprehensive commercial proposal.
Manufacturing & Testing: Precision fabrication, orbital welding, and surface treatment are executed under strict quality controls, followed by rigorous FAT testing.
Delivery & Technical Support: Export-standard secure packaging, delivery of complete documentation, and remote or on-site commissioning and validation support.

 

 

Deep Downstream Processing Experience: We specialize exclusively in fluid separation and purification technologies, enabling us to design hardware rooted in real-world process practicality.
Engineering-Driven Customization: We do not believe in one-size-fits-all. We analyze your molecule's unique sensitivities to craft an optimal fluid path.
Flexible Project Execution: From initial technical consulting and mechanical design to software programming and validation support, we provide end-to-end execution.
Global Export & Compliance Support: Our engineering documentation, electrical components (CE/UL), and pressure vessels can be fully customized to meet the regulatory requirements of your target market.

 

 

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