Nagase Viita – Pharmaceutical Ingredients

Nagase Viita

A world leading supplier of pharmaceutical grade Trehalose

Founded as a starch syrup manufacturer in 1883, Nagase Viita (Formerly Hayashibara Co., Ltd.)  has grown into a company with strong research and development expertise, engaging in original and creative research. Utilizing our technological background in biotechnology and in-depth knowledge of saccharide production, Nagase Viita became the first company in the world to succeed in the mass production of “Trehalose”, a unique disaccharide recognized as a beneficial excipient for the biopharmaceutical industry. In addition to trehalose, Nagase Viita has been supplying for many years other high purity ingredients to the pharmaceutical industry worldwide.


― Nagase Viita’s constant goal is to be a valued supplier in biopharmaceutical development

OUR STRENGTHS:

  • High purity, Low endotoxin grade
  • Experience in industrial saccharide production
  • Integrated production of high purity products starting from saccharide production to purification (endotoxin removal) in our factory in Japan
  • Compliance with all major pharmacopoeias
  • EcoVadis rating in sustainability since 2020

 

Nagase ranked 2024 in the Top one percent of Ecovadis Sustainability Ranking

 

Nagase Viita has been committed to sustainable manufacturing, considering the well-being of people and natural environment as our core importance. We have been awarded the platinum rating, the top 1% of 130,000 assessed companies by EcoVadis, the world’s most trusted assessment organization in France for business sustainability ratings.

 

For Parenteral Biopharmaceuticals

 

Our Unique Brand for Biopharmaceuticals

SOLBIOTETM

SOLBIOTETM was launched with the specific aim of delivering a sustainable solution to biopharmaceutical development.  It features two high-purity and low-endotoxin saccharide excipients, Trehalose SG and Maltose PH.

SOLBIOTETM is making an important contribution to biopharmaceutical drug development, which is enabling manufactures to maintain the high quality of drugs during storage by significantly improving the stability of protein APIs such as antibodies, fusion proteins and immunoglobulins.

SOLBIOTE (TM)
Nagase Viita launches SOLBIOTETM

 

 

High Purity Trehalose

Trehalose SG

Trehalose SG by Hiyashibara
Trehalose SG

Trehalose is a dihydrate crystalline  non-reducing disaccharide  consisting of two glucose molecules  linked by an α,α‒1,1 bond. Trehalose SG has been supplied and used for parenteral formulations because of its high purity and low endotoxin specification. Trehalose is unique in its remarkable acid tolerance as well as heat stability and shows no Maillard reaction when heated in solutions containing amino acids. It shows several benefits in stabilizing protein structures when proteins are lyophilized or frozen, and is also known to prevent cells and liposomes from damage during freezing and thawing.

 

APPLICATIONS

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

REGULATORY APPROVALS

  • JP / USP-NF / Ph.Eur. / CP
  • US Type IV DMF, Chinese DMF
  • Kosher, Halal

 

CHARACTERISTICS

Characteristics Trehalose SG by Hayashibara
Characteristics Trehalose SG

 

High Purity Maltose

Maltose PH

Maltose is a reducing disaccharide consisting of two glucose molecules linked by an α-1,4 bond. Maltose PH is highly purified maltose monohydrate crystalline with a low endotoxin specification. It can be used for parenteral applications including injection, intravenous fluid, and cell culture carbon sources.

Applications Maltose PF by Hayashibara
Applications Maltose PH

APPLICATIONS

  • Active ingredient for infusion fluid
  • Solubility enhancer and stabilizer of freeze-dried anti-cancer agents for injection
  • Stabilizer of Immunoglobulins

 

 

REGULATORY APPROVALS

  • JP/ CP
  • US Type II DMF
  • Kosher, Halal

CHARACTERISTICS

Characteristics Maltose PH by Hayashibara
Characteristics Maltose PH

 

For Oral Drug Development

Sugar excipients are often used in solid oral dosage forms such as tablets. They are used for different purposes including taste improvement, tableting and granulation.

Trehalose 100PH by Hayashibara
Trehalose 100PH

High Purity Trehalose

Trehalose 100PH

Trehalose 100PH is a highly purified trehalose without an endotoxin specification. Since it shows great benefit in masking unpleasant taste and odor, Trehalose 100PH can be used in syrup, dry syrup as well as chewable tablets, making it a more preferred additive for oral drug development.

 

APPLICATIONS

  • Additive for oral solutions
    (e.g., stabilizer, taste improver, solubility enhancer for minerals)
  • Excipient for solid oral dosage forms
    (e.g., tablets)

REGULATORY APPROVALS

  • JP / USP-NF / Ph.Eur.
  • Kosher, Halal

Nagase Viita Weblink


Brochures: 

SOLBIOTE_Nagase Viita
SOLBIOTE_Nagase Viita

Injectable Grade of Trehalose SG_Nagase Viita
Injectable Grade of Trehalose SG

Heat Stability of Trehalose SG_Nagase Viita
Heat Stability of Trehalose SG

For Culture Media Use Trehalose SG_Nagase Viita
For Culture Media Use Trehalose SG

For Antibody Purification Use Trehalose SG_Nagase Viita
For Antibody Purification Use Trehalose SG

For DNA RNA Stabilization Trehalose SG_Nagase Viita
For DNA RNA Stabilization Trehalose SG

For Lyophilization of Exosomes Trehalose SG_Nagase Viita
For Lyophilization of Exosomes Trehalose SG

For Exosome Production and Storage Trehalose SG_Nagase Viita
For Exosome Production and Storage Trehalose SG

For Culture Media_Maltose PH_Nagase Viita
For Culture Media_Maltose PH

Injectable Grade of Maltose PH_Nagase Viita
Injectable Grade of Maltose PH

Trehalose 100PH_Nagase Viita
Trehalose 100PH


Contact

NAGASE & CO., LTD.
Life & Healthcare Products Department

Pharmaceutical Ingredients | Contact us | Nagase Viita Co., Ltd.


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