A novel high throughput plate-based method for 2-PE quantification in novel multidose vaccines (R21 malaria, Covishield and Covovax) and combination vaccines (Hexavalent).

Multidose presentation of vaccines is the most preferred choice, for mass immunization particularly during pandemics. WHO also recommends multidose containers of fill finished vaccines for programmatic suitability and global immunizations programmes. However, multidose vaccine presentations requires inclusion of preservatives to prevent contaminations.

Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens.

Methylated derivatives of cyclodextrins such as DIMEB (2,6-di-O-methyl)-β-cyclodextrin or Heptakis is commonly used as culture medium modifier in manufacturing of pertussis antigens for promoting the growth of bacteria. We report here development and validation of a spectrophotometric method for estimation of DIMEB in different product matrices of pertussis vaccine antigens i.e.

Neurovirulence, viscerotropism and immunogenicity of live attenuated yellow fever 17D vaccine virus in non-human primates.

Yellow fever vaccine associated neurovirulence and viscerotropism have been reported by various countries. In this study, the neurovirulence, viscerotropism and immunogenicity of yellow fever vaccine seed lots (master and working) and final product manufactured at Serum Institute of India (SII) were evaluated in cynomolgus monkeys. WHO reference virus 168-73 and Stamaril™ as a control vaccine was used for comparison.

Rapid, high throughput protein estimation method for saponin and alhydrogel adjuvanted R21 VLP Malaria vaccine based on intrinsic fluorescence.

Protein content estimation of recombinant vaccines at drug product (DP) stage is a crucial lot release and stability indicating assay in biopharmaceutical industries. Regulatory bodies such as US-FDA and WHO necessitates the quantitation of protein content to assess process parameters as well as formulation losses. Estimation of protein content at DP stage in presence of adjuvants (e.

Development and application of HPLC-RI and HPLC-MS/MS based methods for quantification of residual deoxycholate levels in pneumococcal polysaccharides.

The analysis of residual sodium deoxycholate (DOC); a detergent of biological origin used in manufacturing of polysaccharide vaccines is challenging due to complex sample matrices and the lack of suitable methods. Here we report, rapid and sensitive high-performance liquid chromatography-refractive index (HPLC-RI) and tandem mass spectrometry (HPLC-MS/MS) methods for estimation of residual DOC in pneumococcal polysaccharides. For HPLC-RI method, separation was achieved using Luna C18 column and mobile phase compositions of acetonitrile: methanol: 20 mM sodium acetate (60:05:35% v/v).