Progress in the Development of a Vi-CRM 197 Conjugate Vaccine 10th International Conference on Typhoid and Other Invasive Salmonelloses Akshay Goel, PhD Sr VP, Technical Development, Biological E. Ltd., Hyderabad, India 05 Apr 2017 1 10th International Conference on Typhoid and Other Invasive Salmonelloses
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Progress in the Development of a Vi-CRM197 Conjugate Vaccine · Progress in the Development of a Vi-CRM 197 Conjugate Vaccine 10th International Conference on Typhoid and Other Invasive
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Progress in the Development of
a Vi-CRM197 Conjugate Vaccine
10th International Conference on Typhoid and Other Invasive Salmonelloses
Akshay Goel, PhD
Sr VP, Technical Development, Biological E. Ltd., Hyderabad, India
05 Apr 2017
110th International Conference on Typhoid and Other Invasive Salmonelloses
BioE’s TCV Monovalent ProjectVi source
• Source of Vi is Citrobacter freundii
• Citrobacter generates Vi PS which is structurally identical to the Vi PS
• High yields, BSL1 provides significant advantages
• Purified Vi PS meets WHO TRS requirements
210th International Conference on Typhoid and Other Invasive Salmonelloses
Vi Fermentation Lots Summary: GMP Campaign
310th International Conference on Typhoid and Other Invasive Salmonelloses
• GMP MCB & WCB
• All regulatory approvals (DCGI) in place for Clin Mfg
• Fermentation carried out at Pilot Scale in GMP Pilot Plant
• Three consecutive GMP lots completed, lots met acceptance criteria
Time (h)
0 2 4 6 8 10 12 14 16 18
OD
at
60
0 n
m
0
10
20
30
40
50
OD> 25
BioE’s TCV Monovalent ProjectCarrier Protein used for Conjugation
• CRM197 used as a carrier protein
• BioE has developed two technology platforms for CRM197• Recombinant C7 based technology platform• Recombinant E.coli based technology platform
• Both technologies result in purified CRM197 which meets predetermined quality attributes
• Both CRM197 technologies have been presented to Indian Regulatory Agency RCGM (Review Committee on Genetic Manipulation)
• BioE is proceeding with the recombinant C7 derived CRM197 for the TCV program
410th International Conference on Typhoid and Other Invasive Salmonelloses