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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312611
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Title:
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Preparation and Qualification of an Internal Rabies Reference Standard for RFFIT: From Present to Future
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Author(s):
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Mohammad Rahman* and Lingyi Zheng
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Companies:
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Sanofi and Sanofi
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Keywords:
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Rabies;
Concordance;
Reference;
LLOQ;
specificity;
Accuracy
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Abstract:
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The rapid fluorescent focus inhibition test (RFFIT) is the “gold standard” assay for measuring rabies virus neutralizing antibodies (RVNA) in sera. The World Health Organization (WHO) encourages standardization across multiple RFFIT assay formats by generating WHO-1 and WHO-2 standard rabies immune globulins (SRIGs), the stocks of which are no longer available. This study sought to establish an internal rabies reference standard (IRRS) by: (1) using human rabies immunoglobulin produced by Sanofi Pasteur (designated IMORAB2) and (2) pooling serum samples obtained from healthy adults immunized with licensed rabies vaccine (GCIRAB1). For both, bulk material was prepared by diluting with serum-free cell culture medium and candidate IRRS was qualified for use in RFFIT according to established proceduresa. The unitage (IU/mL) was assigned by testing candidate IRRS in multiple assay runs by different analysts to generate > 50 results that were assessed and calibrated against WHO-1 and WHO-2 SRIGs. The observed geometric mean concentration (GMC) for IMORAB2 calibrated against WHO-1 and WHO-2 was 1.8 IU/mL and 1.5 IU/mL (precision 18.7% and 17.8%, respectively). The observed GMC for GCIRAB1
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Authors who are presenting talks have a * after their name.
