Key Product Advantages

1. Ultra-Pure Quality for Clinical-Grade Culture

With HCP residue ≤ 10 ng/g, bacterial endotoxin ≤ 0.5 EU/ml, and purity ≥ 99.0%, alongside undetectable exogenous DNA and low multimer content, the product minimizes non-specific interference from contaminating proteins, impurities and exogenous residues. It effectively mitigates risks such as unintended stem cell differentiation, abnormal immune cell activation, and genomic instability, making it an ideal raw material for clinical-grade cell culture and advanced process development.

2. Well-Characterized Molecular Identity with High Homology

Verified by comprehensive peptide mapping analysis, the product achieves ≥ 99.0% peptide coverage and high structural consistency with native human serum albumin. It fully exerts physiological functions including nutrient carrier transport, osmotic pressure maintenance and antioxidant protection, ensuring stable performance of cell culture systems.

3. Liquid Formulation for Ready-to-Use Efficiency

The pre-formulated liquid presentation delivers a precise and consistent protein concentration of 20% ± 1.2%. No weighing or reconstitution is required—simply add the product directly to culture media upon opening. This greatly simplifies media preparation workflows, reduces human error, and lowers microbial contamination risks during reconstitution, aligning with GMP workshop requirements for large-scale aseptic manufacturing.

4. Animal-Free Process for Full Regulatory Compliance

The entire production system is animal-free and serum-free, eliminating the risk of blood-borne viruses, prions, and other exogenous contaminants at the source. It also removes supply chain volatility and traceability challenges associated with plasma-derived raw materials. The product quality system aligns with FDA and EMA regulatory requirements for CGT manufacturing materials, with complete process characterization and quality data to support CMC submissions.

5. Excellent Batch-to-Batch Consistency for Process Locking

Powered by ton-scale industrial fermentation and refined purification processes, the product maintains a low coefficient of variation across key quality attributes. Highly consistent concentration, purity, and activity reduce batch-to-batch variability in cell culture, enabling reliable process locking, comparability studies, and manufacturing scale-up.

Core Quality Specifications

 Primary Application Scenarios

• Clinical-grade stem cell culture: Suitable for serum-free clinical culture of MSCs, hematopoietic stem cells and other adult stem cells, meeting high safety and low-impurity requirements for clinical submission
• iPSC culture and directed differentiation: Ultra-low HCP and endotoxin levels reduce environmental signal interference, preserve stem cell potency and controlled differentiation, and support advanced regenerative medicine R&D
• Clinical-grade immune cell expansion: Provides stable nutrient carrier and antioxidant protection for CAR-T, TCR-T, NK cell and other immunotherapy products, while avoiding non-specific immune cell activation
• Premium serum-free media formulation: Serves as a core component for chemically defined media development, with precise concentration to accelerate formulation locking and industrial manufacturing
• Cell cryopreservation and formulation protection: Acts as a protein stabilizer in cell cryopreservation and final formulation processes to maintain cell viability and product stability

Manufacturing Capacity & Compliance Assurance

ART101L is manufactured at the production base of Tonghua Anrate Biopharmaceutical Co., Ltd. in Jilin, China. Backed by a 50-ton annual production line for recombinant human albumin, it delivers stable supply across the full product lifecycle from pre-clinical research to commercialization, with a planned capacity expansion to 200 tons in 2026.

• Fully domestic production chain, independent from global plasma supply fluctuations, ensuring secure and controllable supply
• Facility certified to ISO 9001:2015 quality management system, with manufacturing operations strictly aligned with GMP standards
• Complete batch production records and Certificates of Analysis (COA) with full traceability, supporting global regulatory submissions

Anrate empowers the CGT industry with advanced biomanufacturing technology. ART101L liquid ultra-pure recombinant human albumin combines exceptional purity and convenient formulation to deliver reliable raw material support for your cell therapy process advancement.

Important Notice