Aminostable

AminoStable (L-alanyl-L-glutamine)

Benefits of Ajinomoto's Production Process:
  • Greater yields
  • Larger batch sizes
  • Higher purity
  • Simpler process
  • Lower costs

L-glutamine has very important roles in vivo. Glutamine supplies nutritional requirements, improves intestinal health and enhances the immune system. Glutamine is also being used in a variety of clinical studies ranging from cancer treatment, radiation and chemotherapy to treatment of shock and more.

In biotechnology, L-glutamine is an essential component for mammalian cell culture medium.


Why Use a Dipeptide?

As essential as glutamine is to supporting daily activities, it has one major drawback. Glutamine is unstable in aqueous solutions and has poor stability in concentrations required for its use as a nutritional agent.

L-alanyl-L-glutamine (Ala-Gln)

Ala-Gln is a dipeptide with a glutamine amino group joined to an alanyl residue. It has excellent stability and is readily soluble in aqueous solutions. Its efficacy has been proven in numerous clinical investigations. Historically, there have been issues around the use of Ala-Gln as an alternative to L-glutamine:

  • The traditional manufacturing process is complicated and costly.
  • Due to the use of solvents and protected forms of amino acids, there has been concern about potential levels of impurities and/or residual solvents in the final product.

Instead of using solvents and extensive purification steps, Ajinomoto discovered an enzyme that allows amino acid residues to be joined together using a biological enzymation process. Thus, the production process is greatly improved.

There are also economic and regulatory benefits to using AminoStable to replace L-glutamine for human therapeutics and biopharmaceutical applications.

Percent Impurities Detected by HPLC

Company Ajinomoto Competitor A Competitor B Competitor C Competitor D Competitor E
Process Enzymation Chemical Synthesis Chemical Synthesis Chemical Synthesis Chemical Synthesis Chemical Synthesis
Lots Analyzed 3 Lots 1 Lot 1 Lot 1 Lot 1 Lot 1 Lot
PCA N.D. N.D. 0.11 0.13 1.29 1.30
Gln N.D. N.D. N.D. N.D. N.D. N.D.
Ala N.D. 0.71 1.33 2.14 7.43 3.09
AlaGlu 0 - 0.3 0.11 0.21 2.01 4.81 4.83
Other Trace 0.48 1.22 2.85 5.21 6.28
Total Impurity 0 - 0.3 1.30 2.87 7.13 18.74 15.50
*Ajinomoto product evaluation is based upon first two production lots. Subsequent production will require the same rigorous testing before claiming this impurity profile.


Ala-Gln Stability Data

Aminostable Aminostable