Transcript 2. Pneumococcal Conjugate Vaccine_Tergene

Indigenous PCV 15 - An affordable, Asia specific
Pneumococcal Conjugate Vaccine –
Current status of development
M. Kuppusamy, Ph.D
Managing Director,
Tergene Biotech Pvt. Ltd.,
Hyderabad
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PCV - 15
Pneumococcal Conjugate Vaccine Design
Serotypes included:
15 types of pneumococcal polysaccharides
1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F, 23F
Source of Strains:
CDC, Atlanta
Carrier protein:
CRM 197 Diphtheria Toxin (Non-recombinant)
Conjugation Chemistry:
Cyanalation, Adipic acid linker, Carbo-di-imide cross linking
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PCV - 15
Vaccine Formulations
PCV 7
PCV 10
PCV 13
PCV 15
4
4
4
4
6B
6B
6B
6B
9V
9V
9V
9V
14
14
14
14
18C
18C
18C
18C
19F
19F
19F
19F
23F
23F
23F
23F
1
1
1
5
5
5
7F
7F
7F
3
3
6A
6A
19A
19A
2
12F
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PCV - 15
Region wise Serotype Coverage
Region
PCV 7
PCV 10
PCV 13
PCV 15
North America
78 %
81 %
88 %
89 %
Europe
67 %
76 %
88 %
89 %
Latin America
53 %
72 %
82 %
83 %
Oceania
65 %
72 %
80 %
83 %
Africa
40 %
63 %
77 %
81 %
Asia
48 %
66 %
74 %
78 %
*
Pneumococcal Regional Serotype Distribution for Pneumococcal AMC TPP, 2008
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PCV - 15
Current Status of PCV - 15
 In House technology development & Proof of concept established in 2010
 Production of GMP lots for pre-clinical and clinical studies under progress
 Commercial launch expected in 4th quarter of 2014
 Project supported by DBT, Govt. of India
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PCV - 15
THANK YOU!
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