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NANJING, China, Feb. 18, 2025 /PRNewswire/ -- PharmaBlock Sciences (Nanjing), Inc. (Stock code: 300725.SZSE) has announced the official launch of its commercial GMP Workshop 503 (W503) at PharmaBlock Zhejiang. The new workshop significantly enhances production capacity and further refines the high-standard GMP manufacturing system, along with advanced automation and the lean operation model, thereby bolstering the company's capabilities in late-phase and commercial manufacturing.
Addressing Increasing Commercial Manufacturing Demands
W503 is specifically designed to cater the demands of late-stage clinical and commercial manufacturing. With a total capacity of 190.6 m³, the workshop is equipped with reactors ranging from 500L to 8,000L, and two clean production lines, enabling full-process production from Registration Starting Materials (RSMs), intermediates to Active Pharmaceutical Ingredients (APIs). The adoption of a modular equipment layout allows for flexible adaptation to multiple concurrent projects and rapid project switching without the risk of cross-contamination, thereby improving operational efficiency.
Additionally, W503 is equipped with a fully enclosed feeding and discharging system that meets the stringent OEB4-level protection standards, ensuring the safe production of highly potent compounds. The commissioning of W503 has expanded the total reactor volume at PharmaBlock Zhejiang to 630 m³, substantially boosting the site's commercial production capacity and providing robust support for efficient and high-quality manufacturing.
Elevating the High-Specification GMP Production System
W503 is built upon a foundation of high-specification hardware and precise process control to ensure that production processes and product quality meet the international regulatory requirements. The clean area of the workshop integrates advanced spray dryer and jet miller, which fulfill the needs of commercial-scale production, and ensure product stability and consistency.
Furthermore, the workshop incorporates precise temperature and pressure control technologies into the production process, combined with automated batch production and clean-in-place procedures. This comprehensive approach ensures that both the production process and product quality adhere to the high standards of GMP.
Enhancing Production Safety and Efficiency Through Automation
W503 has implemented industry-leading process interlock modules that monitor production process parameters in real-time, ensuring the accuracy and safety of the process flow while reducing manual intervention and significantly enhancing overall production safety. The workshop is also equipped with an advanced automatic inertization system that covers reactors, centrifuges, and separation equipment, effectively mitigating risks associated with organic solvents and combustible dust. Automated modes for rinsing, purging, and discharging further ensure efficient production.