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> GMP Manufacturing 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
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
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.
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.The concept of Resilient Supply has been fully integrated into the design and operation of GMP facility. With its intelligent, modular architecture, the facility offers unmatched flexibility and resilience, capable of meeting the diverse and complex demands of GMP-grade critical reagents. By providing high-quality GMP products at competitive prices, we make innovative biologics, including cell therapies, more accessible. Designed specifically for the GMP production of proteins, enzymes, activation beads, and other solutions, our facility is built to support the evolving needs of the life sciences industry.
| Cell Bank / Strain Bank | Process Control | Production Facility |
|---|---|---|
• Serum-free stable cell lines and animal-free E. coli culture systems. • Tiered cell bank and strain bank management with access control and off-site storage. • Comprehensive testing of original host cells (HEK293: 28 items; CHO: 52 items), free from viruses and contaminants, in compliance with USP and ICH Q5 guidelines. • Comprehensive testing of engineered cells (33 items), free from viral and adventitious agents, in compliance with USP requirements. • Vapor-phase liquid nitrogen storage reduces cross-contamination risks with continuous online monitoring of temperature and liquid nitrogen levels. • Cell bank environment compliant with Class C + A standards, with personnel qualified for aseptic operations. • Stability validation of cell banks (genetic, passage, and long-term stability). | • Quality by Design (QbD) approach, with CQA, CPP, and IPC strategies developed during R&D to ensure product safety and efficacy. • Upstream processes using 20L–500L bioreactors, with PAT technology for continuous monitoring of temperature, DO, pH, and other critical parameters. • Specific virus inactivation/removal steps for eukaryotic products to ensure safety. • Online continuous environmental monitoring during formulation filling to enhance aseptic assurance. • 100% inline weighing feedback during filling to ensure accurate dosages. • Aseptic Process Simulation (APS) with 3 consecutive batches and periodic requalification. • Dual redundant sterilizing filtration at the formulation stage with integrity testing before and after filter use. • Regular monitoring and review of process water, gases, and cleanroom environments. | • Continuous equipment qualification and preventive maintenance programs to ensure operational reliability. • Multi-power supply design ensures production continuity. • Compliance with international GMP regulations and ISO standards for process water, gases, and cleanroom environments. • Unidirectional personnel flow and material flow design for critical areas with independent HVAC systems. • Dedicated cell banking workshop to prevent cross-contamination. • Closed single-use bioreactor systems meeting USP Class VI guidance. • Automatic CIP systems for product-specific fillers and chromatography columns to avoid contamination. • Closed-path fluid transfer via pass-through panels with aseptic tube welding. • Fully automated bottle washing, drying, sterilization, filling, and capping processes to minimize human contamination. • Strict Class B + A production environment with extended Class A laminar flow protection. • Continuous online environmental monitoring to ensure aseptic conditions. • Single-use sterilizing filters and filling systems to prevent cross-contamination. |
| Raw Materials | Personnel | Quality System |
|---|---|---|
• Clear origin and complete traceability for host cells. • Antibiotic-free cell bank cultivation. • Defined, chemical-composition media (AOF/serum-free) for cell culture. • Animal-free raw materials (AOF / no TSE/BSE) used throughout production. • Pharmaceutical-grade excipients and packaging materials. • Tiered supplier management, with regular audits and quality agreements to ensure supply reliability. | • Key personnel with over 20 years of experience in biopharmaceutical production and quality management, supported by a production team of 50+ staff and a quality team of 100+. • Annual health and infectious disease screenings. • Staff hygiene training. • Cleanroom access control. • Personnel number control for critical operating areas. • Verification of personnel gowning qualifications and aseptic operation credentials. | • Quality system compliant with EMA/FDA GMP requirements and ISO 9001/ISO 13485 standards. • Automated and intelligent document management via DMS. • Continuous quality improvement through deviation, change, CAPA, and risk management. • Materials, intermediates, bulk, and final product release management. • Comprehensive validation across the product lifecycle (process, analytical methods, computerized systems, APS, transport, equipment, facilities, utilities, storage, packaging). • FDA 21 CFR Part 11-compliant computerized management platform. • ALCOA+ compliant data integrity control strategy. |
| Quality Control | Technology Transfer | Warehousing & Logistics |
|---|---|---|
• Testing for adventitious contaminants: sterility, endotoxins, mycoplasma, and viruses. • Sterility Testing: Complies with USP<71>. • Endotoxin Testing: Complies with USP<85>. • Mycoplasma Testing: Complies with USP<63>. • Process residual testing: HCP, HCD, etc. • HCP Testing: Complies with USP<1103>. • HCD Testing: Complies with USP<509>. • Animal toxicity testing for certain products: abnormal toxicity, acute toxicity assessments. • Analytical method validation in accordance with ICH Q2 and USP, ensuring accuracy and reliability. • Comprehensive product stability testing (acceleration, long-term, freeze-thaw). • Instrument and equipment validation and audit trail management in compliance with FDA 21 CFR Part 11. | • Adherence to WHO guidelines for pharmaceutical technology transfer, ensuring product consistency during transfers. • The transferring party provides a comprehensive technology transfer documentation package, including process development reports, process specifications, quality standards, validation protocols, analytical method validation reports, material lists and quality control specifications, equipment lists, cell line testing reports, and product stability data. • Receiving site performs new product assessments, gap analysis, and risk evaluations to control technology transfer risks. • The receiving party conducts equipment and facility qualification, aseptic process simulation, personnel training, environmental qualification, implementation of production process and batch records, and analytical method validation. • Strict comparability studies for switching production sites. • Experienced technology transfer team (60+ personnel), managing 25+ projects annually and handling 40+ customer and third-party audits. | • Packaging tested to meet international standards (ISTA 3A-2018 (2022)). • Adequate, well-equipped temperature-controlled storage with independent sampling rooms. • Well-defined warehouse classification and quality management system. • Verified temperature monitoring (Testo) and material/product management system (SAP). • Safety stock management and MRP systems to support production. • Unique identifiers for full lifecycle product traceability. • AI-driven dynamic product demand forecasting to ensure continuous supply. • Four global warehouse and logistics centers providing efficient services worldwide. • Temperature-controlled logistics provided by internationally renowned companies ensure global transportation safety for products. • Professional customs team ensuring efficient and compliant global imports/exports. |
• 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 System for Critical Materials in CGT
• Topic 4: Global Supply Chain Security for Critical Materials in CGT
• Topic 5: Regulatory Compliance for Critical Materials in CGT
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