PharmaBlock Launches Commercial GMP Workshop 503 at Zhejiang Site

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.

Achieving Economic and Environmental Benefits through Lean Management

In line with the principles of green manufacturing, W503 has adopted a series of measures to achieve efficient and environmentally friendly production. Through process optimization, upgraded utility systems, and the introduction of energy-efficient equipment, W503 has significantly reduced operational energy consumption and hazardous waste emissions. Additionally, an advanced digital energy dashboard monitors real-time energy usage at key production nodes, enabling dynamic adjustments to production strategies for cost-effective and eco-friendly operations. This not only enhances the economic benefits of commercial production, but also greatly improves environmental benefits, driving sustainable development.

PharmaBlock Zhejiang now operates six GMP workshops for RSMs, intermediates and APIs, capable of providing end-to-end services from early CMC development to commercial supply for global clients. In recent years, PharmaBlock has seen a steady increase in the delivery of late-stage clinical and commercial projects, successfully helping multiple clients obtain regulatory approvals for their APIs. Its quality management system and commercial capabilities have garnered increasing international recognition.

Dr. Minmin Yang, Chairman of PharmaBlock, said, "The launch of W503 marks a comprehensive upgrade in our commercial capabilities. We are committed to not only expanding our production capacity but also leveraging technological innovation and efficient management to shorten drug launch cycles and reduce costs for our partners. Moving forward, we will continue to expand our global footprint, promote low-carbon manufacturing, and drive sustainable development, bringing our added value to the innovation and development of the global pharmaceutical industry."

SOURCE PharmaBlock