ART103S Recombinant Human Serum Albumin (rHSA)

Animal-Free Lyophilized HSA for Serum-Free CGT Cell Culture

As cell and gene therapy (CGT) rapidly transitions from lab research to full-scale industrial production, raw material quality and supply reliability have become critical bottlenecks for commercialization. Globally, over 100 CGT products have received marketing approval, with more than 3,000 active development pipelines and nearly 2,000 ongoing clinical trials as of the end of 2025.

For decades, plasma-derived human serum albumin (pHSA) has been a standard component in cell culture media. However, tightening regulatory oversight of human- and animal-derived materials has exposed inherent limitations of pHSA in biosafety, traceability and supply chain resilience. Recombinant human serum albumin (rHSA) has emerged as the preferred compliant alternative for modern CGT manufacturing, delivering defined composition, animal-free production and consistent batch-to-batch performance.

Challenges of Plasma-Derived HSA in CGT Manufacturing

Traditional pHSA presents three core risks that no longer align with current GMP and regulatory expectations for CGT production:

I.Biosafety vulnerabilities

Plasma sourcing carries inherent risks of blood-borne virus and prion contamination. Variations across donor pools also lead to unpredictable batch-to-batch differences in quality and functional performance.

II.Fragile global supply chains

pHSA availability relies entirely on plasma collection networks, which are vulnerable to disruption from geopolitical events and public health emergencies, creating long-term supply risks for CGT manufacturers scaling production.

III.Elevating regulatory requirements

In 2024, the FDA released draft guidance strengthening oversight of human- and animal-derived materials in CGT and tissue-engineered product manufacturing, requiring full characterization of source origin, quality attributes, viral safety and risk controls in CMC submissions. The EMA also enforces strict full-lifecycle quality management for plasma-derived materials, making chemically defined, animal-free media components the industry default expectation.

Product Introduction

Core Value Propositions

• ≥99.0% purity with tightly controlled impurity levels to minimize non-specific cellular interference
• 100% animal-free process eliminates blood-borne contamination risks at the source
• Lyophilized powder format for extended shelf life, flexible handling and low-risk transportation
• Exceptional batch consistency to support process locking and comparability studies
• Complete regulatory documentation aligned with FDA and EMA requirements to streamline CMC submissions

Technical Specifications

 Advantages of Lyophilized Powder Formulation

• Long-term stability: 24-month shelf life 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 fluctuations across liquid batches

For applications requiring ultra-low HCP levels (e.g., clinical-grade stem cell culture), our ART101S ultra-pure grade with HCP ≤ 10 ng/g is also available.

Proven Applications in CGT Cell Culture

MSC Serum-Free Culture

T Cell, NK Cell & CAR-T Ex Vivo Expansion

Why Partner With Anrate

• Guaranteed batch consistency: Large-scale single-batch fermentation combined with refined purification processes delivers a low coefficient of variation for key quality indicators across production runs.
• Resilient supply chain: Our fully domestic Chinese production chain is independent of global plasma supply fluctuations, ensuring stable delivery even during market disruptions and geopolitical uncertainty.
• Cost-efficient scaling: Economies of scale reduce unit costs, making high-quality rHSA accessible for both early clinical development and long-term commercial supply.
• Certified quality system: Our manufacturing facility holds ISO 9001:2015 certification and operates under GMP-aligned management standards, with complete batch records and full traceability to support global regulatory submissions.

Ideal Use Scenarios

• Serum-free culture of MSCs and iPSCs, where high purity and flexible formulation are required
• CAR-T, T cell and NK cell expansion, where low endotoxin levels prevent non-specific immune cell activation
• Industrial-scale media preparation, supported by 100g pack sizes, 24-month shelf life and ton-level production capacity
• Process development and validation, where excellent batch-to-batch consistency supports process locking and comparability studies
• Cell culture systems sensitive to host cell proteins, where controlled HCP levels ensure reliable and reproducible cellular performance

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