We adopt a design philosophy of process prioritization and system integration. During the process development phase, we utilize a digital twin platform to simulate the overall material flow and key parameters across upstream and downstream processes, ensuring efficient matching between bioreactor output and downstream capture and purification steps. All core equipment shares the same control system, enabling data connectivity and closed-loop process optimization.
Yes. Our hardware and software platforms strictly adhere to cGMP, FDA 21 CFR Part 11, and EU GMP Annex 11 standards. We provide a complete Validation Support Documentation Package (VSR), including templates for Design Qualification (DQ), Installation/Operational/Performance Qualification (IQ/OQ/PQ), assisting clients in passing global regulatory reviews.
Yes. This is our core service—an integrated "from gene to product" solution. We have a synthetic biology team and a process development platform that can offer full-chain collaboration, from strain construction, screening, process development, scale-up, to factory design, delivering a pilot-verified complete process package.
Yes. We provide integrated solutions ranging from continuous perfusion fermentation, continuous harvesting, to continuous downstream purification (e.g., continuous chromatography, tangential flow filtration). Our intelligent control system enables steady-state operation, real-time monitoring, and automatic adjustments, significantly improving productivity and reducing facility footprint.
Our platform incorporates built-in data integrity management (following the ALCOA+ principles), supporting electronic signatures, audit trails, and role-based access controls. Additionally, the platform features Industrial Internet of Things (IIoT) interfaces for integration with your MES/ERP systems. It also provides process data analysis, digital twin simulation, and AI optimization modules, truly enabling data-driven smart production.
Yes. We have technical service centers and partner networks in Europe, North America, and Asia, offering remote commissioning guidance, on-site installation validation, operator training, and year-round technical support. We also provide multilingual documentation and compliance files to ensure the smooth delivery and long-term stable operation of global projects.
