Bringing Sustainable Solutions to Biopharmaceuticals

Nagase Viita, the first company in the world to mass produce Trehalose, offers solutions for biopharmaceutical development through our signature brand of SOLBIOTE™. It features high-purity, low-endotoxin Trehalose (TREHALOSE SG) and Maltose (MALTOSE PH) saccharide-based pharmaceutical excipients. We confidently offer a stable supply of SOLBIOTE™ as an integrated manufacturer of the Trehalose and Maltose, guaranteeing exceptional quality.

solbiote's commitment: break down below

Stability solutions

  • SOLBIOTE™ is an excellent protein stabilizer
  • Protects cells, nucleotides, and exosomes against damage from drying, freezing, and thawing
  • Preserves the quality of antibody therapeutics and vaccines during storage and distribution

Exceptional quality

  • High-purity and low-endotoxin
  • Complies with the global regulatory requirements of the pharmaceutical industry
  • Achieve superior quality with our extensive knowledge and expertise in saccharide production

Portfolio

trehalose SG

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  • Highly purified Trehalose dihydrate crystalline with a low endotoxin specification
  • Does not participate in the Maillard reaction
  • Remarkable heat and acid resistance
  • High in glass transition temperature (Tg, T’g)

Applications

  • Stabilization of antibodies, peptides, and vaccines for injection
  • Stabilization of exosomes
  • Additive for culture medium (e.g., stem cells)
  • Preservation of platelets

maltose PH

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  • Highly purified Maltose monohydrate crystalline with a low endotoxin specification
  • Good water solubility
  • Compatible with oils

Applications

  • Active ingredient for infusion fluid
  • Solubility enhancer and stabilizer of freeze-dried anti-cancer agents for injection
  • Stabilizer of Immunoglobulins
  • Carbon source of culture medium
Grade Injection Grade
Product Name trehalose SG maltose PH
Purity≧99.0%(Trehalose)≧98.0%(Maltose)
Endotoxin<0.3 EU/g<0.6 EU/g
Regulatory
Approval 		JP✓✓
USP-NF✓
Ph. Eur.✓
CP✓✓
US DMFType IVType II
China DMFF20170000105(A)F20200000041( I )
OtherKosher✓✓
Halal✓✓

Sustainable manufacturing and stable supply

  • Utilize starch and enzymes derived from soil microorganisms
  • Trehalose dihydrate crystalline and Maltose monohydrate crystalline are highly purified with a low endotoxin specification
  • No solvents listed in ICH Q3C Class 1, 2 or 3 are used through manufacturing processes
  • Our integrated manufacturing process ensures exceptional quality control and a stable supply by overseeing the procurement of raw materials, to saccharide production and purification in our factory in Japan.

  • Procurement of raw materials and resources

    Our commitment to responsible procurement ensures raw materials (e.g. starch) are obtained without deforestation or human rights violations.

  • Environmentally friendly saccharide production

    Utilizing starch and enzymes, Trehalose and Maltose are produced efficiently through strategic inventory management and manufacturing planning; minimize waste and CO2 emissions, and preserve water resources.

  • Purification and recrystallization

    Process of purification and recrystallization to produce highly purified Trehalose and Maltose with a low endotoxin specification.

For our dedication to sustainable manufacturing, human rights, and procurement, we have been awarded a Platinum rating by EcoVadis, a sustainability survey organization in France covering over 180 countries. Platinum is the highest rank, given to the top 1% of over 130,000 companies assessed.
We sincerely continue to commit sustainability and social responsibilities towards a better future of the people and the Earth.

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Performance Data