ART103S GMP-Grade Recombinant HSA | Bulk Supply for CGT Industrial Bioproduction

Compliant Animal-Free Raw Material for Industrial-Scale Bioproduction

High Batch Consistency · Global Regulatory Alignment · Stable Bulk Supply

Core Industrial Value

Three Key Advantages for Industrial-Scale Manufacturing

I.Full-Process Compliance for Global Regulatory Requirements

The non-human, animal-free recombinant expression process eliminates biosafety risks associated with plasma-derived materials at the source. With clear traceability and full manufacturing transparency, it fully aligns with the chemically defined raw material expectations of the FDA and EMA. Complete quality documentation is available to support efficient CMC dossier submission and reduce compliance investment.

II. Strict Quality Control for Superior Batch-to-Batch Consistency

Powered by mature large-scale fermentation and multi-step purification processes, key product indicators comprehensively outperform industry standards, with controlled variation of core activity parameters across batches. This effectively reduces process validation workload, ensures stable and repeatable manufacturing processes at scale, and lowers batch rejection risks.

III.Ton-Scale Production Capacity for Long-Term Stable Supply

The in-house production base realizes fully domestic and independent manufacturing, free from fluctuations in the international plasma supply chain. It supports simultaneous bulk stocking for multiple clients, fully matching enterprise capacity ramp-up and long-term commercial production demands.
 

Key Quality Specifications (Typical Batch Data)

Every batch undergoes strict release testing, with measured performance generally exceeding standard requirements. The following data represents typical batch results; specific values are subject to the Certificate of Analysis of delivered batches.
 

Data from corresponding batch Certificate of Analysis. Specific indicators are subject to the actual delivered batch.

Lyophilized Powder Formulation, Designed for Industrial Formulation

• Long Shelf Life for Bulk Stocking: 24-month validity at 2-8°C supports large-volume procurement and inventory, reducing management and logistics costs from frequent purchasing
• Direct Weighing for Streamlined Production: Powder can be directly weighed and dosed into media systems without pre-dissolution or concentration calibration, suitable for hundred-liter to ton-scale media formulation
• Low-Risk Logistics for Reliable Delivery: Temperature control achieved with ice packs, with no risk of liquid leakage, ensuring stable quality during long-distance, multi-node transportation
• Flexible Reconstitution for Diverse Formulations: Dissolvable in sterile water or PBS up to 200 mg/mL, with on-demand dilution to support different media formulation development and optimization

Application-Specific Process Solutions

Serum-Free Culture of Mesenchymal Stem Cells (MSC)
Low HCP residual and high purity reduce unintended interference from impurity proteins and lower abnormal differentiation risks. The solid powder enables accurate weighing and adapts to full-stage process scale-up from R&D to production.
 
 In Vitro Expansion of Immune Cells (CAR-T / T / NK)
Ultra-low endotoxin level avoids non-specific immune cell activation. The carrier transport and antioxidant functions of albumin improve expansion efficiency and cell viability, ensuring uniform quality across individual batches.
 
Culture and Differentiation of Induced Pluripotent Stem Cells (iPSC)
Stringent impurity control minimizes exogenous signal interference and preserves genomic stability, making it suitable for clinical-grade cell culture systems with extremely high raw material purity requirements.
 
Commercial-Scale Media Manufacturing
Available in 10g and 100g specifications with ton-level stable production capacity, supporting bulk procurement for media manufacturers. Excellent batch-to-batch consistency reduces formulation validation costs and ensures stable quality of finished media products.

Supply & Service Assurance

• Capacity Assurance: The Jilin production base operates a 50-ton annual production line, with a 200-ton expansion planned for 2026 to meet simultaneous commercial production demand from multiple clients
• Quality System: Factory certified to ISO 9001:2015, following GMP management specifications with full manufacturing traceability; complete quality documentation for regulatory submission is available
• Customized Services: Custom packaging specifications available upon request, supported by technical consultation and regulatory documentation support
• Supply Chain Resilience: Fully domestic production layout with minimal exposure to external environmental fluctuations, delivering strong supply resilience

Important Notice