ART103S Recombinant Human Albumin (rHSA) | HSA for Serum-Free Cell Culture

Compliant Raw Material for CGT Industrial-Scale Production

Navigate Regulatory Updates · Eliminate Plasma Dependency · Enable Industrial Manufacturing

Product Overview

Cell and Gene Therapy (CGT) has entered a rapid phase of industrial development, with over 100 approved products and 3,000+ R&D pipelines worldwide. As regulators tighten requirements for full-process manufacturing control, traditional plasma-derived human serum albumin presents growing limitations in batch consistency, supply continuity, and regulatory compliance.

Produced with a Pichia pastoris eukaryotic expression system and a fully animal-free manufacturing process, ART103S is designed exclusively for serum-free and chemically defined cell culture media. It addresses the core limitations of plasma-derived raw materials at the source, serving as a premium raw material solution for CGT industrial upgrading.

Key Quality Specifications

Backed by mature fermentation and purification processes, key product indicators comprehensively exceed standard requirements with highly controllable batch-to-batch consistency, suitable for high-standard cell culture systems.

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

Advantages of Lyophilized Powder Formulation

• Long-Term Stability: 24-month shelf life at 2-8°C, reducing storage and inventory management costs
• Flexible Preparation: Dissolvable in sterile water or PBS up to 200 mg/mL for on-demand dilution and aliquoting. The powder form can be directly weighed and dosed, free from concentration fluctuations of liquid batches
• Convenient Transportation: Temperature control achieved with ice packs, no risk of liquid leakage, reducing logistics losses
• Precise Control: High weighing accuracy of solid powder supports batch recording and full process traceability for large-scale media preparation

Core Application Scenarios

• Serum-Free Stem Cell Culture (MSC / iPSC): High-purity, low-impurity protein profile reduces non-target signal interference and unintended differentiation risks, adapting to formulation development and large-scale production scale-up
• In Vitro Immune Cell Expansion (CAR-T / T Cells / NK Cells): Low endotoxin level avoids non-specific immune cell activation; delivers carrier transport, osmotic pressure maintenance and antioxidant effects to improve expansion efficiency and cell viability, ensuring uniform batch quality
• Industrial-Scale Media Manufacturing: Available in 10g and 100g specifications, matched with ton-level stable production capacity to support bulk procurement and long-term stocking; excellent batch-to-batch consistency ensures stable large-scale production processes
• Process Development & Regulatory Validation: Controllable variation of key activity indicators across batches accelerates process locking, and supports comparability studies and process transfer for clinical submission

Production Capacity & Compliance Assurance

• Large-Scale Capacity: The Jilin production base operates a 50-ton annual production line, with a 200-ton expansion planned for 2026 to fully match the rapid growth of the industry
• Fully Independent Supply Chain: Entire production process is domestically controlled, free from international plasma supply chain fluctuations with strong supply resilience
• Standardized Quality System: Factory certified to ISO 9001:2015, following GMP management specifications with full-process quality traceability
• Controllable Cost: Large-scale production reduces unit cost, providing stable cost expectations for long-term mass production

Important Notice