Abstract
The measurement uncertainty in quantifying polysaccharides in glycoconjugate vaccines was estimated in order to ascertain compliance of these products in the batch release procedure of an Official Medicines Control Laboratory. A single-laboratory validation approach of an internal analytical procedure to quantify the total saccharide by the way of the sialic acid (N-Acetylneuraminic acid) concentration in a meningococcal glycoconjugate vaccine by High Performance Anion Exchange Chromatography coupled with Pulsed Amperometric Detection is reported. Uncertainty components from precision, bias and other sources were evaluated. It turned out that uncertainty is dominated by the precision contribution, while bias was mainly due to the non-recovery from hydrolysis. As a consequence, a correction factor was considered. At a confidence level of approximately 95%, the expanded uncertainty of the total polysaccharide concentration in a vaccine, when measured using the internal method, was found to be 11.5%.
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Acknowledgement
We thank Dr. Giuseppina Mandarino for the help in revision and editing of the manuscript. We acknowledge Novartis Vaccines and Diagnostics s.r.l. (Italy) to kindly provide us MenC polysaccharide and MenC-CRM vaccine.
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Susanna Murtas and Andrea Gaggioli contributed equally to this work.
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Murtas, S., Gaggioli, A. & von Hunolstein, C. Quantifying uncertainty in determination of polysaccharides in glycoconjugate vaccines based on in-house validation data. Accred Qual Assur 17, 177–182 (2012). https://doi.org/10.1007/s00769-012-0876-4
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DOI: https://doi.org/10.1007/s00769-012-0876-4