ACROBiosystems Expands Suzhou GMP Facility with Phase II Launch, Enhancing Resilient Supply

In July 2026, ACROBiosystems Suzhou GMP Factory Phase II was completed and put into operation. The project comprises a prokaryotic bulk solution production line and a cell bank production line. Currently, the prokaryotic bulk solution production line has successfully completed trial production and multiple batches of GMP product manufacturing. This marks that ACROBiosystems has now achieved end-to-end production and supply capability for GMP-critical core raw materials used in commercial cell and gene therapy manufacturing.

Following the Phase II facility going into operation, ACROBiosystems has further enhanced its independent supply capability for GMP-grade products. In addition to the existing eukaryotic bulk solution production and formulation capabilities across various product types, the company has added prokaryotic bulk solution and GMP-grade cell line production, enabling it to provide global customers with more direct, more comprehensive, more stable, and more efficient product and service support.

Since the Suzhou facility Phase I went into operation in 2024, it has successfully produced nearly 100 high-quality GMP-grade products，including cytokines, antibodies and magnetic beads for cell activation, universal nucleases, Cas enzymes, media and kits. The commissioning of Phase II will further leverage the economies of scale of GMP manufacturing, continuously improving production efficiency and cost advantages.

The vision of ACROBiosystems Suzhou GMP Intelligent Facility is to be a high-quality, flexible, and supply-chain-resilient bio-reagents and materials manufacturing base for the future biopharmaceutical market. Looking ahead, the facility will continue to strengthen its independent production capacity and quality management systems, empowering global biomedical customers to accelerate drug development and commercialization with high-quality, high-reliability critical reagents and solutions.

About ACROBiosystems Suzhou GMP Intelligent Facility

The facility opened in June 2024, covering an area of 5.4 acres with a total gross floor area of over 50,000 m². The site features an intelligent, modular design with outstanding production flexibility, enabling it to undertake a wide range of complex production tasks and fully meet customers' diverse supply needs for GMP-grade core raw materials. At the same time, keeping pace with the evolving cell therapy technologies, it leverages its innovation laboratory to continuously develop innovative products and solutions, and possesses the capability to rapidly upgrade GMP-grade products and translate them into industrial production.

As an Audit-Ready (ADR) facility that can undergo both on-site and remote audits worldwide at any time, the base has obtained ISO 9001, ISO GMP, MDSAP, and EXCiPACT certifications, and has successfully passed the audit of the Rx-360 International Pharmaceutical Supply Chain Consortium, with its production system fully aligned with the mainstream regulatory requirements of China, the United States, Europe, and Japan. The cleanrooms are laid out in a scientific manner, and a rigorous aseptic control system and strategy have been established. The site houses independent GMP workshops for cell banking, bulk solution, formulation, and magnetic beads, supported by a 2,200 m² QC laboratory, and is capable of 10–500 L bulk solution production as well as filling and testing of multiple formulation specifications. In addition, systems such as BMS, EMS, SAP, TESTO, and TSI enable real-time monitoring and traceability of the facility environment, equipment operation, and warehousing and logistics. These systems, together with DMS and TMS, comply with FDA CFR 21 Part 11 requirements and have completed computerized system validation, meeting data integrity and reliability requirements.

About ACROBiosystems Group

ACROBiosystems Group, founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and healthcare industries by providing innovative products and business models. The company spans across the globe and maintains offices, R&D centers, and production bases in 16 cities across the United States, Switzerland, the United Kingdom, and Germany. ACROBiosystems Group has established numerous long-term and stable partnerships with the world's top pharmaceutical enterprises and numerous well-known academic institutes. The company comprises several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.

It is committed to providing innovative products and solutions to overcome challenges in the entire process of biopharmaceutical R&D, production, and clinical application. Its main products and services are recombinant proteins, kits, antibodies, scientific services, and other related products. ACROBiosystems employs a strict quality control system for its products that are used in biopharmaceutical research and development, production, and clinical application. This includes targeted discovery and validation, candidate drug screening/optimization, CMC development and pilot production, preclinical research, clinical trials, commercial production, and clinical application of companion diagnostics. ACROBiosystems' brands include Resilient Supply, CytoPak, SAFENSURE, FLAG, Star Staining, Aneuro, ComboX, GENPower, and many others.

ACROBiosystems upholds its brand core values: reliable quality, integrated innovation, considerate service. Through the continuous development of new technologies and products, ACROBiosystems Group creates value for the global pharmaceutical industry and actively empowers our partners. The company is dedicated to accelerating the drug development process, including targeted therapies, immunotherapeutic drugs and their clinical applications, and contributes to global health.