HAYASHIBARA – Pharmaceutical Ingredients

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A world leading supplier of pharmaceutical grade Trehalose

Founded as a starch syrup manufacturer in 1883, Hayashibara 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, Hayashibara 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, Hayashibara has been supplying for many years other high purity ingredients to the pharmaceutical industry worldwide.


Hayashibara’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 GOLD rating in sustainability

 

EcoVadis GOLD rating in sustainability in 2022 for Hayashibara
EcoVadis GOLD rating in sustainability in 2022

OUR PRODUCTS:

For Parenteral Biopharmaceuticals

In the development of biotechnology-based therapeutics, such as antibody medicine, sugar excipients are often used in formulations to stabilize protein APIs.
The following are our two main products for parenteral applications, injectable grade Trehalose SG and Maltose PH.

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
  • Additive for culture medium (e.g., stem cells)
  • Preservation of platelets

REGULATORY APPROVALS

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

Hayashibara Homepage:

Pharmaceutical Ingredients Products Information | Pharmaceutical Ingredients | HAYASHIBARA Co., Ltd. Cosmetic & Pharmaceutical Ingredients


Brochures:

Hayashibara Trehalose SG for protein stabilization
Trehalose SG – Protein stabilization
Trehalose SG - Heat Stabililty
Trehalose SG – Heat Stabililty
Hayashibara Trehalose for antibody purification buffer
Trehalose for antibody purification buffer
Hayashibara Trehalose SG for Cell Culture Medium
Trehalose SG for Cell Culture Medium
Hayashibara Trehalose SG for DNA/RNA Stabilization
Trehalose SG for DNA/RNA Stabilization
Trehalose SF for Exosome Stabilization
Trehalose SF for Exosome Stabilization
Trehalose SG Exosome Production and Storage
Trehalose SG Exosome Production and Storage
Hayashibara Maltose PH - General Leaflet
Maltose PH – General Leaflet
Hayashibara Maltose PH for Culture Media
Maltose PH for Culture Media
Trehalose 100 PH
Trehalose 100 PH General Leaflet

Contact

NAGASE & CO., LTD.
Life & Healthcare Products Department
Pharma-Medicals Division
Contact

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