In May 2026, with the implementation of State Council Decrees No. 818 and No. 828, China’s cell therapy industry is entering a more standardized and system-driven stage. Regulatory focus is shifting from “encouraging innovation” to balancing innovation with safety, upgrading from partial rules to comprehensive governance.
Policy highlights:
Decree 818 (manufacturing): Strengthens GMP and full-process quality control, emphasizing “controllability.”
Decree 828 (regulation): Enhances lifecycle supervision and traceability, emphasizing “traceability.”
Industry impact:
Laboratory consumables are being redefined with higher entry thresholds. Suppliers are now expected to provide biocompatibility and extractables data, ensure full batch traceability, and meet increased audit requirements.
Overall, these policies are driving the industry from a manufacturing-focused model toward a quality system–driven approach, accelerating the shift to higher standards, stronger validation, and stricter compliance.
1. NEST TriSteri™ Ultra-Low Particulate Products
Under increasingly stringent regulatory and quality requirements, NEST has launched TriSteri™ ultra-low particulate product line, designed for high-cleanliness applications such as cell and gene therapy, providing reliable consumable solutions for advanced biopharma and research.
Applications (GMP-critical processes):
Suitable for large-scale cell culture, aseptic bulk filling, API sampling, formulation filling, and high-cleanliness reagent transfer.
Key advantages:
Ultra-low particulate control: Tested per Chinese Pharmacopoeia (light obscuration method); results significantly below limits, reducing contamination risk.
Strict quality inspection: Dual visual inspections ensure no visible particles.
Certified quality system: Sterility level SAL 10⁻⁶; free from DNase/RNase, endotoxins, and cytotoxicity; compliant with ISO 13485 and ISO 9001.
Triple-layer packaging: GMP-compliant design to prevent contamination and enhance aseptic operation safety.
Validation & compliance: Systematic testing supports high standards for biopharmaceutical production and research accuracy.
2. “Hard Requirements” for Laboratory Consumables
With evolving regulations, lab consumables must meet not just single performance metrics, but a comprehensive system of capabilities: raw material safety, GMP-level manufacturing, sterility assurance, and data integrity—areas where many companies still face gaps.
01 High-quality raw materials
Medical-grade materials compliant with USP Class VI ensure defined composition, stability, and no animal-derived components, reducing risks of cytotoxicity, extractables, and variability.
02 GMP manufacturing & automation
GMP-compliant cleanrooms and advanced automated equipment (e.g., ASB systems) enable standardized processes from raw materials to delivery, minimizing contamination and ensuring batch consistency.
03 Sterility assurance
In-house sterilization center equipped with IBA Rhodotron® accelerators ensures SAL 10⁻⁶, meeting FDA requirements with stable and effective sterilization control.
04 Third-party validation
Comprehensive testing, including biocompatibility, cytotoxicity, and extractables/leachables, supported by complete validation and audit documentation—shifting from “claimed safety” to “proven safety.”
05 Full traceability
Upgraded packaging and data systems with QR-coded COA/COC enable batch traceability, supporting audits, compliance checks, and integration with customer quality systems.
3. Integrated Product Portfolio
With over a decade of experience in life sciences, NEST has expanded from laboratory consumables to medical devices, pharmaceutical packaging, biobanking solutions, and bioprocess components—driven by continuous innovation and a commitment to high-end consumables.
01 Laboratory consumables
Covering cell culture, microbiology, molecular biology, and bioprocessing, NEST products are made from high-quality materials with precision molds and fully automated production, ensuring sterility, non-pyrogenicity, and non-cytotoxicity. A wide range of specifications supports diverse experimental needs.
02 Pharmaceutical packaging
Includes disposable pen injectors, prefilled automatic pen injectors, TSA pen injectors, pen injectors, and ready-to-use (RTU) solutions.
The implementation of Decrees 818 and 828 is not a constraint, but a shift toward rebuilding industry trust. Future competition will depend on product stability, system robustness, and data reliability.
NEST remains committed to high-standard materials, advanced manufacturing, strict sterility assurance, and comprehensive validation—delivering reliable, verifiable quality in an evolving regulatory landscape.
