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GMP Recombinant Human Serum Albumin

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

GMP-grade recombinant human serum albumin for cell culture
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HSA01-GMP-50ML

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

Product 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.

Product Specifications

Source

Pichia pastoris

Sterility Testing

Tested following USP <71> sterility guidelines.

Scientific Data Images 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.

Kit Contents for GMP Recombinant Human Serum Albumin

50 mL of GMP Recombinant Human Serum Albumin

Formulation, Preparation, and Storage

Shipping

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.

Product Documents for GMP Recombinant Human Serum Albumin

Certificate of Analysis

To download a Certificate of Analysis, please enter a lot or batch number in the search box below.

Note: Certificate of Analysis not available for kit components.

Product Specific Notices for GMP Recombinant Human Serum Albumin

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.
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