Amoytop Biotech is an innovative biopharmaceutical enterprise listed on the STAR Market. With decades long expertise in recombinant proteins and long acting modified drugs, it hosts high end R&D platforms including a national level post doctoral research workstation and a national engineering research center. Recognized as a National Innovative Enterprise and National Key High Tech Enterprise, the company leverages its proprietary core technology platforms to develop flagship products and innovative pipelines focusing on immunology and metabolism, Wellthinic Technology delivered a customized integrated digital intelligent system encompassing EMS, MES and SCADA for Amoytop Biotech. Driven by data and intelligent management, the solution enables compliant and efficient operation across the full production workflow. It helps the customer build a modern biopharmaceutical smart manufacturing system featuring high standards, high reliability and high level integration.
Solution Description:
Wellthinic Technology provides an in depth IT/OT convergence solution centered on the core objective of a “shared digital and business collaboration platform”. Built upon a data driven full lifecycle digital service system and leveraging Siemens’ world leading digital platforms, the solution takes low voltage network and construction works as foundational support. It implements a three tier isolated industrial Ethernet architecture consisting of field control network, monitoring aggregation network and production management network. The scope covers shopfloor comprehensive cabling, industrial switch deployment, cabinet assembly, optical fiber link laying, network security isolation, IP planning, VLAN segmentation and firewall configuration.Integrating the three core modules of EMS, MES and SCADA together with lean management methods, the solution establishes a closed loop digital workflow for the entire production process and forms an integrated architecture of “infrastructure plus core systems”, interconnecting data links across the equipment layer, monitoring layer and management layer.The entire construction process strictly complies with clean room construction specifications and industrial automation grounding standards. System joint commissioning, protocol interconnection and cross system data interaction tests are completed to build a stable, secure and scalable underlying digital foundation for the smart factory. It supports unified digital management covering process monitoring, environmental surveillance and production process traceability.
Expected Outcomes:
Establish an intelligent operation system covering the full production workflow and realize electronic management with full process traceability for production batch records.
Meet GMP compliance requirements and quality control needs through dual safeguards of production execution and data monitoring, enabling “second level response” for quality traceability.
Enable linkage between equipment operation data and raw material parameters, ensuring automatic recording and accurate matching of every data point from raw material feeding to finished product output.
The intelligent data aggregation platform empowers management to accurately identify high cost links, improving operational efficiency and overall competitiveness.
