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Amino acid composition of biologics

Determination of amino acid composition by quantitative amino acid analysis

Want to confirm the exact amino acid composition of your drug substance protein?

We offer determination of the exact amino acid composition of your drug substance protein. We do this by ion chromatography on an amino acid analyzer.

ICH Q6B (Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) requires determination of the amino acid composition of your drug substance.

The sample is hydrolyzed into free amino acids. Then separated by ion exchange chromatography on an amino acid analyzer. Hereby you obtain accurate quantification of 14 individual amino acids: Ala, Arg, Gly, His, Ile, Leu, Lys, Met, Phe, Pro, Ser, The, Tyr, Val. Furthermore, you obtain the total quantity of Asn/Asp as well as the total quantity of Gln/Glu. Trp and Cys cannot be quantified by this method.

Service includes

  • Hydrolysis of sample.
  • Ion exchange chromatography on an amino acid analyzer.
  • Quantification of 18 amino acids.
  • 3 replicates and accuracy within +/- 5%.
  • Calculation of amino acid composition.
  • Comparison with theoretical drug substance sequence.

Send us a project request for a customized analysis.

Services/Products
Protein analysis by Alphalyse

Amino acid composition of drug substance

  • Amino acid composition determination
  • 3 replicates, accuracy within +/- 5%
  • Comparison with protein amino acid sequence

$1,100.00

World Class Service
Quality analysis, presented in easy-to-understand reports
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Protein analysis by Alphalyse

Amino acid composition of drug substance (customized)

  • Customized hydrolysis procedure: time-course, special amino acids, glycerol formulation..
  • Amino acid composition determination, 3 replicates, accuracy +/- 5%
  • Comparison with protein amino acid sequence

World Class Service
Quality analysis, presented in easy-to-understand reports
Info / Order
Request quote
Order analysis now
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