Trehalose SG (IVD)

High-purity carbohydrate for stabilization of biomolecules in diagnostics and therapeutics.
Supports protein, peptide, and cell preservation with proven biocompatibility and lot-to-lot consistency.

Reliable Biostabilizer for IVD, Biopharma, and Cell-Based Applications

Trehalose SG is a high-purity, non-reducing disaccharide developed by Nagase Viita – a NAGASE Group company – to meet the stringent requirements of the IVD and biopharmaceutical sectors.

Manufacturing IVD requires long-term storage of analyte-specific reagents (ASR) such as enzymes, antibodies, nucleic acids, and exosomes. Ensuring the stability of ASR is crucial in order to preserve their full functionality up to their expiration date.

The primary application of trehalose in IVD, is for the production, purification, and preservation of antibodies.11 The stability of an antibody has a significant impact on its performance (specificity and affinity).12 Hence antibodies used in industry are often formulated as solids by using drying techni¬ques such as freeze-drying and spray-drying to extend their shelf life.

A study demonstrated that trehalose reduced aggregation in 3 different IgG1 antibodies.11 Another reported that mAbs in ELISA kits extended the shelf life, while also decreasing the background signal noise via its effect on the specific reactivity of the antigen binding sites

Trehalose is used by Diagnostic companies to stabilize DNA/RNA for PCR analysis. The stable storage of nucleic acids from clinical samples is important for accurate molecular diagnostics.

NAGASE supplies Trehalose SG worldwide for in vitro diagnostics, regenerative medicine, and injectable drug formulation.

Applications

Trehalose SG is used across IVD and biopharma industries to stabilize sensitive biomolecules and cell-based systems.

  • Antibody and peptide stabilization – Prevents degradation during freeze-drying or thermal stress
  • Protein-based therapeutics – Stabilizer in injection formulations and lyophilized drugs
  • Cell culture media – Additive for stem cell viability and cryopreservation
  • Platelet storage – Extends shelf life and function of preserved platelets
  • In vitro diagnostics – Preserves assay sensitivity and stability in reagent kits

Features

Trehalose SG offers high purity, excellent biocompatibility, and broad stabilizing functionality for diagnostic and therapeutic use.

  • High purity (>99%) – Ultra-low impurities, ideal for sensitive biological formulations
  • Non-reducing sugar – Chemically stable and non-reactive with proteins or nucleotides
  • Biocompatible and inert – Widely used in injectable and cell-contact applications
  • Excellent solubility – Easily dissolves in aqueous buffers and media
  • GMP-aligned production – Consistent quality with full traceability and regulatory support

Additional Information

Purity: 99 – 101 % (low endotoxin)
Regulatory Approval: JP, USP-NF, Ph. Eur., CP
Others: US type IV DMF, Kosher, Halal

Packaging Size

  • 1 kg PE bag
  • 20 kg PE bag (carton box)
  • 20 kg PE bag (plastic container)

Frequently Asked Questions about Trehalose SG (IVD Grade)

What is Trehalose SG used for in IVD applications?
Trehalose SG stabilizes antibodies, enzymes, and nucleotides in diagnostic reagents, helping maintain sensitivity and shelf life.

How does it benefit protein or peptide-based drugs?
It prevents aggregation and denaturation during formulation, freeze-drying, or long-term storage of protein therapeutics.

Is Trehalose SG suitable for cell culture or stem cell media?
Yes, it enhances viability and reduces osmotic or oxidative stress, making it useful in stem cell preservation and regenerative medicine.

Can it be used in injectable formulations?
Absolutely. Trehalose SG is high-purity, non-toxic, and suitable for injection-based products, including vaccines and biological drugs.

Is regulatory documentation available?
Yes. NAGASE provides full documentation including CoA, traceability, and regulatory support for Trehalose SG.

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In Vitro Diagnostics

Volker Wagner
Sales Manager