Overview
As the flagship intelligent manufacturing ecosystem of ACROBiosystems Group, this next-generation GMP facility is designed with modular architecture and digital integration. It aims to be a high-quality, flexible, and supply-chain-resilient bio-reagents and materials manufacturing base toward the future biopharmaceutical market. Resilient Supply & ADR — Hallmarks of this GMP facility. Online and on-site visits are warmly welcomed.
$90 million
Investment5.4 acres
AreaSuzhou, China
Location
Resilient Supply offers flexible, low-risk, high-quality GMP solutions to accelerate the development and commercialization of CGT biologics.
As an Audit-Ready (ADR) facility, we maintain continuous readiness for both virtual and on-site audits.You are welcome to visit us at any time!
GMP Facility
Flexible and Resilient Supply Chain
Cleanroom & Infrastructure
Advanced utility infrastructure including process water, pure steam, and process gas. Cleanroom environments are rigorously classified based on GMP and ISO standard, with independent HVAC systems and unidirectional personnel/materials flows to prevent cross-contamination.
Scale & Product Portfolio
Features strategically zoned production buildings, with dedicated zones for manufacturing, QC, warehouse, utilities, and more.
Formulation Filling & Monitoring
Formulation filling area accommodates glass vials (2R to 50R), bags, and PETG bottles. 100% in-line weighing and online continuous environmental monitoring during formulation filling (oRABS: B+A Grade, Isolator: C+A Grade).
Digital System & Compliance
Powered by a fully validated computerized ecosystem (BMS, EMS, TESTO, SAP, DMS, TMS) compliant with FDA 21 CFR Part 11, ensuring real-time environmental monitoring, automated data integrity, and seamless batch traceability.
Uninterrupted Power & Redundancy
Including dual-grid feeds, emergency diesel generators, and Uninterruptible Power Supply (UPS) systems, ensuring uninterrupted manufacturing operations.
Dual-Sourcing & Continuity
Operates under a dual-source strategy for critical raw materials, equipment, and consumables, backed by an established backup plan for core manufacturing activities.
GMP Quality Management Systems
We combine data integrity, world-class equipment, and meticulous validation protocols to guarantee exceptional batch-to-batch consistency and regulatory compliance.
Global Regulatory Compliance
Fully aligned with international regulatory frameworks (FDA, EMA, NMPA, PMDA, MFDS) to support seamless global IND/BLA submissions. Globally recognized, holding ISO 9001, ISO GMP，EXCiPACT, ISO 13485, MDSAP, and Rx-360 certifications.
Strict Sterility & Contamination Control
Employs a comprehensive Contamination Control Strategy (CCS), including a redundant sterile filtration process, single-use closed systems, and regular risk-based Aseptic Process Simulation (APS/media fills).
Expert Quality Team
Backed by an agile, cross-functional operations team where 85% are highly educated (bachelor's degree or above) and 65% possess over 5 years of pharma experience. Over 40% of the site's headcount is dedicated strictly to Quality Unit.
Key Advantages
Driving Efficiency, Quality, and Supply Security in CGT Manufacturing
Cell Bank / Strain Bank
All of Cell seeds from ECACC- Chemically defined, animal-origin-free, pharmaceutical-grade culture media
- Cell line passed by 26 external quality control tests
- Comprehensive cell bank security ensured by real-time temperature/liquid nitrogen monitoring, access control, and dual-person dual-lock protocols
Capacity and Process Control
- Upstream processes using 10L-500L bioreactors, continuous monitoring of temperature, DO, pH, and other critical parameters (C+A Grade)
- Downstream processing capacities from 150 mL/min to 3 L/min, specific virus inactivation/removal steps for eukaryotic products to ensure safety (C+A Grade)
- Accommodate glass vials (2R to 50R), bags, and bottles. 100% in-line weighing and online continuous environmental monitoring during aseptic filling (oRABS: B+A Grade, Isolator: C+A Grade)
- APS (Aseptic Process Simulation) and periodic requalification
- Routine monitoring of process water, gases, and cleanroom environments
Raw Materials and Suppliers
- Animal-free raw materials (AOF / no TSE/BSE) used throughout production
- Pharmaceutical-grade excipients and packaging materials
- Raw materials are fully tested in accordance with the quality specifications
- Stringent supplier management process: sourcing and screening, classification, qualification and auditing, re-assessment and on-site evaluation
- Tiered supplier management, quality agreements and change notifications
Personnel
- Key personnel with over 10 years of experience in biopharmaceutical production and quality management
- Annual health and infectious disease screenings
- Staff hygiene training and aseptic operation credentials
- Maximum personnel limit for critical operating areas
- Personnel gowning qualifications for Grade B areas
Quality Control
- Product testing for adventitious agents: sterility (USP<71>/EP 2.6.1), endotoxins (USP<85>/EP 2.6.14), mycoplasma (USP<63>/EP 2.6.7)
- Process residual testing: HCP (USP<1103>), HCD (USP<509>), etc.
- Analytical method validation in accordance with ICH Q2, USP and EP
- Comprehensive product stability testing (acceleration, long-term, freeze-thaw)
- Instrument audit trail complies with FDA 21 CFR Part 11
Warehousing & Logistics
- Packaging tested to meet international standards (ISTA 3A-2018 (2022))
- Validated temperature monitoring (Testo) and product management system (SAP)
- Unique identifiers for full lifecycle product tracking
- Four global warehouse and logistics centers
- Professional customs team ensuring efficient and compliant global imports/exports
Global Trust
We have successfully hosted both virtual and on-site visits and audits for global clients, earning their trust and recognition.