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> GMP Product Safety Control Strategy 
ACROBiosystems GMP grade products have been designed and considered in accordance with the regulatory requirements of various countries to ensure the safety of the entire production and quality control process, including external contaminations, fully guaranteeing the safety of the products. We are committed to developing high-quality GMP grade raw materials and reagents for the clinical commercial production stage of cell and gene therapy. Combining drug production standards with stricter quality management and release testing standards, we provide customers with truly GMP grade products!
The production cell lines are well-documented and traceable to ECACC as the source.
HEK293 host cells undergo domestication, establishment, and comprehensive testing (28 items) by an internationally renowned third-party organization, compliant with the U.S.P. and ICH Q5 guidelines.
The production cell lines undergo further testing after the construction of the cell bank. The testing, conducted by a well-known third-party testing organization, compliant with the U.S.P. and ICH Q5.
The upstream cell culture stage uses chemically defined medium (CDM) as well-defined culture medium. All materials used in the upstream production process are serum-free (SF) and animal-origin-free (AOF). Cell recovery and amplification are performed in a biosafety cabinet (BSC) located in Class C area. Disposable closed systems and aseptic welding technology are employed during bioreactor production, with strict separation of production stages to minimize the risk of contamination.
During downstream purification process virus removal/inactivation steps such as low pH treatment and nanofiltration are introduced. Viral clearance process validation is also conducted (in progress) for critical steps. The purification process utilizes project-specific separation columns and chromatographic media to avoid cross-contamination risks between different production stages.
The formulation production is carried out in a strict Grade B+A production environment. After sterilizing filtration, the semi-finished product is processed using fully automated equipment and a single-use sterile filling system. Aseptic operations (e.g., component assembly, filling, stoppering, lyophilization) are performed in a B+A-grade clean environment, monitored by a PMS continuous environmental monitoring system. After lyophilization, vials are capped in a Grade C+A environment. The finished products undergo visual inspection, labeling. After the completion of full test base on quality specification, product release will be conducted by quality assurance.
Rigorous sterile process validation and packaging seal integrity validation: Sterile process validation includes APS (Aseptic Process Simulation) using appropriate sterile medium and/or product surrogates. APS evaluates all aseptic operations from sterilization of materials to container sealing, considering normal production and worst-case scenarios. For GMP grade products, each packaging component undergoes sterile process validation before first batch production, with periodic revalidation via quality risk assessment. Packaging seal integrity, vital for product sterility and quality, is validated using microbial ingress and tracer methods, and tested during long-term stability studies to ensure aseptic reliability.
For production-related raw materials, excipients and packaging materials, priority has been given to selecting pharmaceutical-grade materials registered with CDE (Center for Drug Evaluation). All materials used in GMP product manufacturing are evaluated and classified through joint assessment by R&D, production, and quality teams. For critical materials, quality standards are established by referencing regulatory requirements and pharmacopoeial specifications, with critical characterization analyses being conducted accordingly.
Final product quality control release：
- External factor detection: sterility, endotoxins, mycoplasma, exogenous viruses, etc
- Residual detection of various process impurities: antibiotics, HCP, HCD, etc
- A total of 13-16 QC quality inspection items
- Product CoA, Product Release Form
- Monitoring and measuring equipment have been calibrated, and key analytical instruments have been validated through 3Q
- The analysis method has been comprehensively validated
- key analytical instruments have activated audit trail capabilities
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