GMP Facility
- As the flagship intelligent manufacturing ecosystem of ACROBiosystems Group, this next-generation GMP facility is designed with modular architecture and digital integration, offering operational resilience for complex biologics production and flexible supply chain solutions for GMP-grade core materials. Equipped with future-ready infrastructure, the facility supports continuous advancements in cell therapy platforms through integrated innovation labs, enabling rapid GMP-grade product development and seamless technology commercialization. Certified as an Audit-Ready (ADR) Facility, it maintains global audit readiness for both virtual and on-site audit.
- Compliant with US FDA, EMA, and international GMP regulation, ensuring validation for global submissions.
- Advanced Product Solutions: A full GMP biologics portfolio, including cytokines, antibodies, enzymes, magnetic beads, and media, supporting CGT therapeutics from discovery to commercial production.
Join us for an exclusive 1-2 hour virtual tour of ACROBiosystems' state-of-the-art GMP facility! Explore our advanced manufacturing, learn about our GMP capabilities, and engage in a live Q&A with our experts. Gain insights into cutting-edge CGT ancillary material manufacturing processes and explore potential collaborations.
Scientifically designed cleanroom layouts: The bulk solution manufacturing area is classified C+A clean rooms, and the aseptic formulation area meets B+A cleanliness levels, complying with pharmaceutical-grade cleanliness control requirements.
Rigorous APS validation: Aseptic production processes are periodically simulated using sterile nutrient media, with regular confirmation of personnel's aseptic operation qualifications.
Each area has independent HVAC control, with key zones featuring unidirectional personnel flow and material flow to support colinear production. The process water quality is controlled in accordance with the USP and EP and continuously monitored to ensure reliability.
The computerized management platform complies with FDA 21 CFR Part 11, covering everything from utilities to document management systems, electronic clocks to automatic data backups, enhancing work efficiency, automation, traceability, and data integrity.
The temperature monitoring system and warehouse/material management system (SAP) are validated, with separate areas for quarantined materials, released materials, and rejected materials, ensuring complete material management and quality control.
GMP Production Team
- Over 20 years of production management experience in the biotech industry
- More than 10 years of experience in the commercialization of sterile formulation production
- Over 3,000㎡ of GMP-certified cleanroom space
Quality Management Team
- A dedicated team of 100+ experienced quality professionals
- A state-of-the-art QC laboratory spanning nearly 3,000㎡
- Over 10 years of expertise in quality management within the pharmaceutical industry
R&D and Technology Transfer Team
- Successfully delivered over 5,000 recombinant protein development projects
- Over 10 years of specialized expertise in protein development, production, and process scale-up
ACROBiosystems GMP Facility Quality System Overview
Our GMP facility is built to meet global regulatory standards, including US FDA, EMA, ICH, and ISO 9001/13485 standards. We adhere to best practices in managing biologically sourced materials for cell and gene therapy production, integrating ICH risk management principles for continuous, efficient quality assurance. With ISO 9001 and GMP certifications, our experienced quality team is equipped to navigate the complexities of biopharmaceutical regulations worldwide. We stay ahead of industry trends, adapting our quality systems to meet the unique needs of each client and product, ensuring compliance with evolving regulations and delivering exceptional results.
Explore Our GMP Brand – Resilient Supply
Addressing key challenges in the cell and gene therapy industry—such as quality fluctuations, supply chain risks, and regulatory uncertainties—Resilient Supply offers flexible, low-risk, high-quality GMP solutions to accelerate the development and commercialization of CGT biologics.
Core Advantages of Resilient Supply, Pioneering New Horizons in CGT Manufacturing!
More Contents
Related Resources
• Topic 1: Controlling External Contaminants in the Production of Critical Materials for CGT
• Topic 2: Aseptic Protection Strategies for Critical Material Production in CGT
• Topic 3: Quality Control Strategies for Critical Materials in CGT
• Topic 4: Regulatory Compliance for Critical Materials in CGT
• Topic 5: Supply Chain Security for Critical Materials in CGT
Voice of Customer
March 3, 2025
Nanjing Legend Biotech Delegation Visits ACROBiosystems GMP Facility
"ACROBiosystems’ GMP facility delivered a tremendous surprise through its advanced design philosophy, international-standard infrastructure, and exceptional team expertise. This is unequivocally a world-class operation – one that confirms our conviction to pursue collaborative partnerships across global markets. At Nanjing Legend, we seek deep collaborative partnerships with suppliers. ACRO’s comprehensive product portfolio and custom capabilities serve as a solid foundation for this vision."
— Xu Weiyun
Procurement Director, China
Nanjing Legend Biotech
- GMP Smart Factory
- ACROBiosystems GMP Facility Quality System Overview
- Explore Our GMP Brand – Resilient Supply
- Core Advantages of Resilient Supply, Pioneering New Horizons in CGT Manufacturing!
- More Contents
- Related Resources
- Voice of Customer
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[North America]: 1 Innovation Way, Newark, DE 19711, USA [Switzerland]: ACRObiosystems AG, c/o Zug Dammstrasse Centre AG, Dammstrasse 19, 6300 Zug Switzerland
Email：order@acrobiosystems.com
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