50L to 500L Pilot-Scale Bioreactor System

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Process-Driven Biopharmaceutical Equipment Integration

Our 50L–500L pilot-scale bioreactor systems deliver fully GMP-aligned, scalable process development platforms bridging laboratory small-scale testing and commercial biomanufacturing. Purpose-built for mammalian cell culture, microbial fermentation, viral vector amplification, vaccine antigen propagation and recombinant protein expression, the modular skid design resolves core pilot-stage challenges including inconsistent scale-up parameters, limited process monitoring precision, poor batch reproducibility and fragmented data recording. The product line covers flexible volume configurations from 50L, 100L, 200L, 300L up to 500L, supporting process characterization, media screening, feeding strategy validation and full process qualification before full-scale production deployment. Equipped with integrated sanitary piping, real-time multi-parameter sensing and automated closed-loop control, the pilot bioreactor platform delivers highly repeatable cultivation results, generates reliable scale-up datasets and drastically cuts technical risks for subsequent commercial line investment.

Core Design Philosophy

We adhere to the core design principle of Scale-Up Consistency, Low-Shear Biomolecule Protection, and Compact Skid Integration, optimizing tank geometry, agitation aeration architecture and control logic to maintain identical hydrodynamic and cultivation microenvironment across all volume tiers within the 50L–500L range. The design prioritizes data transferability to eliminate scale-up gaps common between pilot and commercial stages.

Homologous Scale-Up Geometry Matching: Uniform tank aspect ratio, impeller type and sparger layout across all 50L–500L models, ensuring consistent oxygen transfer rate, mixing efficiency and shear force to preserve cell viability and target product expression level.

High-Precision Multi-Parameter Closed-Loop Control: Independent automatic regulation of temperature, pH, dissolved oxygen, agitation speed, overlay gas flow and feeding volume, with ultra-sensitive real-time sensors for stable long-duration batch and fed-batch cultivation.

Dead-Zero Sanitary Aseptic Construction: Full mirror-polished wetted stainless steel surfaces, smooth arc transitions and self-draining piping, fully compatible with validated automated CIP/SIP cycles to eliminate cross-contamination and residual carryover between batches.

Plug-and-Play Compact Skid Frame: All tanks, control cabinets, utility manifolds and sampling ports pre-integrated on unified skid bases, minimizing on-site installation workload and shortening facility validation cycles for pilot workshops.

Authoritative Global Compliance System

All mechanical structures, contact materials and intelligent control software comply with international bioprocess engineering and quality standards, providing complete equipment qualification documents to support process validation, regulatory audit and CMC filing.

Biopharmaceutical Sanitary Engineering Standards: Wetted components adopt pharmaceutical-grade 316L stainless steel with low protein adsorption, fully compliant with cGMP and ISPE sanitary equipment design specifications.

Full Data Integrity & Audit Trail Compliance: Built-in control system meets FDA 21 CFR Part 11 requirements, automatically archiving all cultivation parameters with tamper-proof electronic records for full batch traceability.

Cross-Product Regulatory Adaptability: Cultivation logic and material certification satisfy ICH, FDA and EMA guidelines for biologics, vaccines and biosimilar process development, supporting global clinical trial registration.

Full-Scope System Configuration & Technical Services

We provide one-stop customized services covering volume matching, functional module configuration, factory pre-commissioning, on-site installation and long-term process technical support.

Customized Volume & Functional Module Matching: Select targeted tank capacity from 50L to 500L, configure optional perfusion harvesting systems, automatic sampling devices and cold holding vessels based on specific cultivation workflows.

Integrated Skid Assembly & Pre-Factory Debugging: Complete full system assembly, hydraulic testing and multi-batch simulation operation in factory, delivering pre-validated skids to shorten on-site commissioning time.

On-Site Installation, Training & Process Guidance: Provide professional pipeline docking, system commissioning, operator training and scale-up parameter consulting to maximize target product titer and batch stability.

Complete Validation Dossiers & After-Sales Support: Deliver full equipment qualification IQ/OQ/PQ documents, operation manuals and sensor calibration protocols, with ongoing technical assistance for process iteration and capacity expansion.