GMP Recombinant Human Serum Albumin

Name: GMP Recombinant Human Serum Albumin
Brand: R&D Systems
SKU: HSA01-GMP-50ML

R&D Systems, part of Bio-Techne | Catalog # HSA01-GMP-50ML

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Product Datasheet / COA / SDS

GMP-grade recombinant human serum albumin for cell culture

Key Product Details

Features:	An animal-free, cGMP manufactured, and high purity (≥ 98.0%) protein solution that delivers proven biological performance by enhancing cell expansion in serum-free, clinical grade cell culture workflows.
Key Benefits:	Animal‑free production to eliminate contamination risks and simplify regulatory compliance cGMP‑manufactured for consistency, traceability, and suitability in clinical and commercial cell therapy workflows High purity and monomer content ensures reliable performance, even in sensitive cell culture applications Stable, ready-to-use format for work in process development or media manufacturing

Technical Data
Citations / Reviews

Summary for GMP Recombinant Human Serum Albumin

Why Use GMP Recombinant Human Serum Albumin?

GMP Recombinant Human Serum Albumin is the ideal choice for advanced cell therapy development and serum-free media manufacturing because it combines fully animal-free, Pichia pastoris–derived production with cGMP manufacturing to deliver exceptional quality, consistency, and regulatory readiness. Its high purity (≥ 98%) and strong monomer content ensure reliable culture performance, with demonstrated ability to enhance NK cell and iPSC expansion and provide functional advantages. With a ready-to-use format, this recombinant HSA reduces process variability and supports robust, scalable, and compliant therapeutic manufacturing.

Kit Contents for GMP Recombinant Human Serum Albumin

50 mL of GMP Recombinant Human Serum Albumin

Product Specifications for GMP Recombinant Human Serum Albumin

Formulation	Liquid
Source	Pichia pastoris
Sterility Testing	Tested following USP <71> sterility guidelines.

Limitations

For preclinical, or clinical ex vivo use. Not for in vivo use.

The safety and efficacy of this product in diagnostic or other clinical uses has not been established.
This reagent should not be used beyond the expiration date indicated on the CoA.

Scientific Data Examples for GMP Recombinant Human Serum Albumin

	Molecular Weight by SEC-MALS. GMP Recombinant Human Serum Albumin (Catalog # HSA01-GMP-50ML) has a molecular weight of 64.9 kDa as analyzed by SEC-MALS.
	Fold Expansion of PBMC-Derived NK Cells. Addition of GMP Recombinant Human Serum Albumin (Catalog # HSA01-GMP-50ML) to a commercially available NK medium supports the expansion of primary human PBMC-derived NK cells compared to minimal expansion with Supplier P or no HSA supplementation. Results are statistically significant, with p-value less than 0.05 using a t-test.
	iPSC Colony Morphology and Expansion Rates With GMP Recombinant HSA. Human iPSC grown in commercially available media supplemented with GMP Recombinant Human Serum Albumin (Catalog # HSA01-GMP-50ML) demonstrate normal iPSC colony morphology. Colonies cultured with GMP Recombinant Human Serum Albumin demonstrate increased expansion rate compared to cells in media without supplementation.

Preparation & Storage

Shipping Conditions	The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended on the product label.
Storage	Store at 2-8 °C, protected from light. Refer to lot specific COA for the Use by Date.

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