HSA Human Recombinant Albumin GMP Compliant For Serum Free CGT Cell Culture
Recombinant Human Albumin A Compliant Raw Material Solution for Serum-Free CGT Cell Culture
ART103S: High-Purity Recombinant Human Albumin Expressed in Pichia pastoris
ART103S recombinant human albumin from Anrate is developed with a Pichia pastoris expression system and a completely animal-free manufacturing workflow, purpose-built for serum-free and chemically defined cell culture media.
Core Quality Specifications
- Purity: ≥ 99.0%
- Molecular weight: 66.5±6.7 kDa
- Host cell protein (HCP) residue: ≤ 500 ng/g
- Endotoxin: ≤ 0.5 EU/mg
- pH range: 6.4–7.4
- Protein content: 95.0–110.0%
- Microbiological limit: ≤ 10 cfu/g
- Formulation: Lyophilized powder
- Pack sizes: 10 g / 100 g
The lyophilized powder format delivers practical advantages across the full product lifecycle:
- Long shelf life: 24 months of stability when stored at 2–8°C
- Flexible reconstitution: Dissolvable in sterile water or PBS up to 200 mg/mL, with customizable dilution and aliquoting
- Simplified logistics: Shipped with ice packs, eliminating liquid leakage and breakage risks
- Precise formulation: Direct weighing for media preparation, free from concentration variations across liquid product batches
Verified Performance Across CGT Culture Scenarios
MSC Serum-Free Culture
As the most widely studied adult stem cell type with over 1,400 registered clinical trials, MSCs have traditionally relied on FBS or human platelet lysate (hPL) in culture—materials with high batch-to-batch variation and inherent xenogeneic contamination risks. As a core component of serum-free MSC media, recombinant human albumin supports osmotic pressure homeostasis, fatty acid and metabolite transport, and antioxidant protection. The solid powder format enables accurate dosing and complete batch documentation for large-scale media manufacturing.
Immune Cell Expansion (T Cells, NK Cells, CAR-T)
For autologous CAR-T therapies, where each batch is manufactured for a single patient, raw material variability can directly impact final product quality and consistency. In serum-free immune cell expansion systems, recombinant human albumin acts as a carrier to bind and sustain the release of fatty acids and fat-soluble vitamins, maintains colloid osmotic pressure to shield cells from osmotic stress, and exerts antioxidant effects via its free cysteine (Cys-34) residue to scavenge reactive oxygen species (ROS) and reduce oxidative damage during in vitro culture.
iPSC Culture and Differentiation
Manufacturing Capacity & Compliance Assurance
ART103S is manufactured at Anrate’s production base in Jilin, China, with a current annual production capacity of 50 tons. A 200-ton production facility is planned for construction in 2026 to support growing commercial demand.
- Consistent batch quality: Large-scale single-batch fermentation coupled with refined purification processes ensures low coefficient of variation for key performance indicators across production runs
- Supply chain resilience: Fully domestic production chain, independent from global plasma supply fluctuations and geopolitical disruptions
- Cost efficiency: Economies of scale reduce unit costs for long-term commercial supply
- Quality system certification: The facility holds ISO 9001:2015 certification and operates under GMP-aligned management standards
Ideal Application Scenarios
- Serum-free culture of MSCs and iPSCs: High-purity powder with accurate weighing and flexible reconstitution, adaptable to custom media formulations
- CAR-T, T cell, and NK cell expansion: Low-endotoxin formulation to avoid non-specific immune cell activation
- Industrial-scale media preparation: 100 g pack size, 24-month shelf life, and ton-level production capacity support bulk procurement
- Process development and validation: Excellent batch-to-batch consistency supports process locking and comparability studies
- HCP-sensitive culture systems: Ultra-low HCP specification suitable for cell types highly sensitive to contaminating proteins
In the advancement of CGT industrialization, every raw material decision represents a long-term trade-off between safety, compliance, and supply chain reliability. Backed by a Pichia pastoris eukaryotic expression system, animal-free manufacturing, ton-level production capacity, and GMP-grade quality control, Anrate recombinant human albumin provides CGT developers with a compliant, controllable, and traceable raw material option for cell culture processes.
Important Notice
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