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Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac ™) at elevated temperatures to support controlled temperature chain (CTC) claim
Biologicals. 2023 Aug 8;83:101698. doi: 10.1016/j.biologicals.2023.101698. Online ahead of print.ABSTRACTMeningococcal A Conjugate Vaccine (MenAfriVac) is the world's first Monovalent Conjugate Vaccine against Neisseria Meningitidis serogroup A which has obtained Controlled Temperature Chain (CTC) label claim of "stable upto 40°C for 4 days prior to reconstitution" developed by Serum Institute of India Pvt. Ltd. Pune, India and the vaccine was granted permission from World health Organization. This paper elucidates and talks about the layout of various studies performed to characterize the product to declare as CTC at the...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 10, 2023 Category: Biotechnology Authors: Sunil Gairola Prashant Bonde Pankaj Sharma Sameer Kale Sunil Goel Suresh Jadhav Source Type: research

Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture
We report a selective ion chromatography method with electrochemical detection using IonPac AS7 column for estimation of residual cyanide in meningococcal serogroups A, C, W, Y and X bulk conjugates in presence of other interfering ions. Gold electrode and Ag/AgCl reference electrode ensures sensitivity and reproducibility of cyanide quantitation. The calibration curve of the method is linear having r2 ≥0.990 over the concentration range 1.45 ng/mL to 93.10 ng/mL. The recovery of cyanide in bulk conjugates ranged between 96.0% and 108.9%. The limits of detection and quantitation were 0.50 ng/mL and 1.45 ng/mL which corre...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 15, 2023 Category: Biotechnology Authors: Saurav Ghosh Ashishkumar Gulhane Pankaj Sharma Sameer Kale Vivek Kangralkar Rakesh Pawar Sunil Kumar Goel Asha D Mallya Rajeev M Dhere Source Type: research

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