Polypeptide New Product Lab-scale and Pilot-scale Production Project скачать в хорошем качестве

Polypeptide New Product Lab-scale and Pilot-scale Production Project

Project Background: Amid accelerated biopharmaceutical R&D, CSPC Pharmaceutical Group requires the construction of a high-activity peptide pilot-scale platform to meet small-scale/pilot-scale process development needs. The project aims to overcome traditional production bottlenecks by addressing pain points such as significant human error in solid-phase synthesis, high exposure risks of organic solvents, and low purification efficiency. Leveraging expertise in intelligent OSD workshops for traditional Chinese medicine, AUSTAR Group adopted a core strategy of "Modular Integration + Full-Process Enclosure" to create China's first turnkey project for solid-phase peptide synthesis, accelerating the transition from R&D to production. Service Scope： Provision of end-to-end equipment and control systems for solid-phase peptide synthesis: Process Modules:Solid-phase synthesis (including DCS-driven synthesizers, modular reactor clusters), Cleavage (corrosion-resistant cleavage reactors), Cyclization: Purification (skid-mounted fraction collection + nanofiltration concentration) Intelligent Systems: MCS material tracking, DCS central control.Enclosure Solutions: Ventilated liquid-dispensing stations ,Integrated sintered base plates AUSTAR Value & Client Benefits： 1.Smart Control DCS systems enable automated orchestration of peptide chain synthesis, cleavage, and purification, with real-time monitoring to intercept process deviations and ensure synthesis stability. Automatic generation of electronic batch records complies with GMP data integrity requirements. 2.Modular Flexible Production Modular reactor clusters support rapid switching of peptide synthesis pathways; skid-mounted purification modules reduce material transfer distances and optimize spatial efficiency. Elevated dissolution tank design prevents cleaning residue, while integrated sintered base plates eliminate dead zones in material collection, reducing impurity risks. 3.Closed-Loop Quality Assurance Micro-dosing systems combined with ventilated dispensing stations enable precise control of volatile solvents and gas isolation. Enclosed residue discharge in cleavage reactors and conical crystallization tank designs minimize exposure points, blocking cross-contamination. Through the tri-technical integration of "Smart Control + Modular Architecture + Closed-Loop Operation", this project achieves full-process precision management for pilot-scale peptide production, delivering an intelligent manufacturing benchmark for high-activity drug transformation. #BiopharmaceuticalR&D #SolidPhaseSynthesis #ModularIntegration #FullProcessEnclosure #SmartControl #AutomatedOrchestration #GMPCompliance #ModularFlexibleProduction #ClosedLoopQualityAssurance #IntelligentManufacturing #AUSTAR