Contemplation of the possibility of extending the shelf life of human immunoglobulin reference standard used for determination of anticomplementary activity
Abstract
The article gives an account of the stability study performed for two batches of human immunoglobulin reference standard (RS) used for determination of anticomplementary activity (industry reference standard, IRS 42-28-430). The first batch of human immunoglobulin reference standard used for determination of anticomplementary activity showed sustainable results during 30 months of storage at (5±3) °C which makes it possible to extend the RS shelf life from 18 months (corresponding to the initial monitoring period) to 30 months from the date of determining the certified parameter, given the acceptable range of more than 50 % for the positive control and less than 50 % for the negative control. Based on the results obtained, the re-certification was performed for the second RS batch after 18 months of storage. The main certified parameter (anticomplementary activity) of the negative control was within the range of 41.6±7.2 %, and of the positive control 75.7±6.8 % for the confidence level of 0.95. Therefore, the shelf life of the second batch of the human immunoglobulin reference standard used for determination of anticomplementary activity (IRS 42-28-430) was extended until February 2018, which makes 30 months.
About the Authors
O. G. Kornilova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
Russian Federation
Chief expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
M. A. Krivykh
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of the Division for Expert Evaluation of Allergenes, Cytokines and Other Immunomodulators of the Center for Evaluation and Control of Medicinal Immunobiological Products
Russian Federation
Leading expert of the Division for Expert Evaluation of Allergenes, Cytokines and Other Immunomodulators of the Center for Evaluation and Control of Medicinal Immunobiological Products
E. A. Husnatdinova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
E. S. Konovalova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Engineering technician of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
Russian Federation
Engineering technician of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
O. V. Fadeykina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
E. Yu. Kudasheva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
A. A. Movsesyants
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Medical Sciences, Professor
Russian Federation
Head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Medical Sciences, Professor
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Review
For citations:
Kornilova O.G., Krivykh M.A., Husnatdinova E.A., Konovalova E.S., Volkova R.A., Fadeykina O.V., Kudasheva E.Yu., Movsesyants A.A. Contemplation of the possibility of extending the shelf life of human immunoglobulin reference standard used for determination of anticomplementary activity. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(2):110-115. (In Russ.)
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