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Multivalent Pneumococcal Conjugate Vaccine

Abstract: Abstract of the invention The present invention relates to a multivalent Pneumococcal conjugate vaccine (PCV) composition comprising: at least 12 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to carrier protein selected from CRM197, pneumococcal surface protein A (PspA), pneumococcal adhesin protein (PsaA) or combination thereof and a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
23 June 2015
Publication Number
02/2017
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
hyderabad@knspartners.com
Parent Application
Patent Number
Legal Status
Grant Date
2021-07-08
Renewal Date

Applicants

Biological E Limited
18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana.

Inventors

1. Ramesh Venkat Matur
Biological E Limited 18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana, India
2. Rajendar Burke
Biological E Limited 18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana, India
3. Thirumeni Nagarajan
Biological E Limited 18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana, India
4. Narender Dev Mantena
Biological E Limited 18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana, India
5. Mahima Datla
Biological E Limited 18/1 & 3, Azamabad, Hyderabad – 500 020, Telangana, India

Specification

We claim:
1. A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
a) at least 12 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to carrier protein selected from CRM197, pneumococcal surface protein A (PspA), pneumococcal adhesin protein (PsaA) or combination thereof and
b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
2. A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
a) at least 14 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to CRM197, PspA, PsaA or combination thereof and
b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.

3. The composition as claimed in claims 1 and 2, further comprises one or more serotypes selected from 6C, 8, 10A, 11 A, 12F, 15A, 23A, 23B and 35B of S. pneumoniae.
4. The composition as claimed in claims 1 and 2, wherein the amount of polysaccharide from each of the serotypes is 1 to 10 ug.
5. The composition as claimed in claims 1 and 2, wherein the amount of carrier protein conjugated to polysaccharide is 3 to 30 ug.

6. The composition as claimed in claim 1, wherein the single 0.5 mL dose contain 2 ug of each polysaccharide; 30-40ug CRM197 carrier protein; 0.2 to 1 mg of aluminum phosphate adjuvant; sodium chloride and buffer.
7. A 14 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
8. A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
9. A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 23F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug of CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
10. A serotype composition for formulating a 13 valent PCV comprising;

a) conjugation of the pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,

c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2um filter,
d) formulation of the 13 valent PCV using 13 monovalent pneumococcal conjugates; 4.4ug for serotype 6B; 2.2ug for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling,
e) wherein the said 13 valent PCV does not contain capsular polysaccharide from serotype 6A.
11. A serotype composition for formulating a 14 valent PCV comprising;
a) conjugation of pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,
c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2um filter and
d) formulation of the 14 valent PCV using monovalent pneumococcal conjugates; 4.4ug for serotype 6B; 2.2ug for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling.

Documents

Orders

Section Controller Decision Date

Application Documents

# Name Date
1 3140-CHE-2015-US(14)-HearingNotice-(HearingDate-11-05-2021).pdf 2021-10-17
1 Provisional Specification - PCV Patent-MultiV-Formulation- Form 2.pdf 2015-06-24
2 3140-CHE-2015-IntimationOfGrant08-07-2021.pdf 2021-07-08
2 FORM 26-Biological.pdf 2015-06-24
3 Other Document [31-05-2016(online)].pdf 2016-05-31
3 3140-CHE-2015-PatentCertificate08-07-2021.pdf 2021-07-08
4 Form13_Address of Service Change_31-05-2016.pdf 2016-05-31
4 3140-CHE-2015-Written submissions and relevant documents [24-05-2021(online)].pdf 2021-05-24
5 Drawing [15-06-2016(online)].pdf 2016-06-15
5 3140-CHE-2015-Correspondence to notify the Controller [07-05-2021(online)].pdf 2021-05-07
6 Description(Complete) [15-06-2016(online)].pdf 2016-06-15
6 3140-CHE-2015-ABSTRACT [09-12-2020(online)].pdf 2020-12-09
7 CERTIFIED COPIES TRANSMISSION TO IB [27-06-2016(online)].pdf 2016-06-27
7 3140-CHE-2015-CLAIMS [09-12-2020(online)].pdf 2020-12-09
8 Assignment [01-07-2016(online)].pdf 2016-07-01
8 3140-CHE-2015-FER_SER_REPLY [09-12-2020(online)].pdf 2020-12-09
9 3140-CHE-2015-FORM 3 [09-12-2020(online)].pdf 2020-12-09
9 3140-CHE-2015-Power of Attorney-070616.pdf 2016-07-22
10 3140-CHE-2015-Correspondence-PA-070616.pdf 2016-07-22
10 3140-CHE-2015-OTHERS [09-12-2020(online)].pdf 2020-12-09
11 3140-CHE-2015-Form 5-050716.pdf 2016-07-27
11 3140-CHE-2015-Proof of Right [09-12-2020(online)].pdf 2020-12-09
12 3140-CHE-2015-Correspondence-F5-COMPLETE SPECIFICATION-050716.pdf 2016-07-27
12 3140-CHE-2015-FER.pdf 2020-06-11
13 3140-CHE-2015--COMPLETE SPECIFICATION-050716.pdf 2016-07-27
13 Correspondence by Agent_Power of Attorney_12-09-2019.pdf 2019-09-12
14 3140-CHE-2015-FORM 13 [09-09-2019(online)].pdf 2019-09-09
14 Form 3 [19-08-2016(online)].pdf 2016-08-19
15 3140-CHE-2015-FORM-26 [09-09-2019(online)].pdf 2019-09-09
15 Form-2(Online).pdf 2016-09-30
16 3140-CHE-2015-FORM 3 [06-09-2019(online)].pdf 2019-09-06
16 Form 3 [02-02-2017(online)].pdf 2017-02-02
17 Form3_After Filing_14-02-2017.pdf 2017-02-14
17 3140-CHE-2015-FORM 3 [03-09-2018(online)].pdf 2018-09-03
18 Correspondence by Agent _Form 3_08-03-2018.pdf 2018-03-08
18 Form26_Power of Attorney_14-02-2017.pdf 2017-02-14
19 3140-CHE-2015-FORM 3 [03-03-2018(online)].pdf 2018-03-03
19 Correspondence by Agent_Power of Attorney_14-02-2017.pdf 2017-02-14
20 Correspondence by Agent_Copy of Form18_11-05-2017.pdf 2017-05-11
20 Form 18 [09-05-2017(online)].pdf 2017-05-09
21 Correspondence by Agent_Copy of Form18_11-05-2017.pdf 2017-05-11
21 Form 18 [09-05-2017(online)].pdf 2017-05-09
22 3140-CHE-2015-FORM 3 [03-03-2018(online)].pdf 2018-03-03
22 Correspondence by Agent_Power of Attorney_14-02-2017.pdf 2017-02-14
23 Correspondence by Agent _Form 3_08-03-2018.pdf 2018-03-08
23 Form26_Power of Attorney_14-02-2017.pdf 2017-02-14
24 Form3_After Filing_14-02-2017.pdf 2017-02-14
24 3140-CHE-2015-FORM 3 [03-09-2018(online)].pdf 2018-09-03
25 3140-CHE-2015-FORM 3 [06-09-2019(online)].pdf 2019-09-06
25 Form 3 [02-02-2017(online)].pdf 2017-02-02
26 3140-CHE-2015-FORM-26 [09-09-2019(online)].pdf 2019-09-09
26 Form-2(Online).pdf 2016-09-30
27 3140-CHE-2015-FORM 13 [09-09-2019(online)].pdf 2019-09-09
27 Form 3 [19-08-2016(online)].pdf 2016-08-19
28 3140-CHE-2015--COMPLETE SPECIFICATION-050716.pdf 2016-07-27
28 Correspondence by Agent_Power of Attorney_12-09-2019.pdf 2019-09-12
29 3140-CHE-2015-Correspondence-F5-COMPLETE SPECIFICATION-050716.pdf 2016-07-27
29 3140-CHE-2015-FER.pdf 2020-06-11
30 3140-CHE-2015-Form 5-050716.pdf 2016-07-27
30 3140-CHE-2015-Proof of Right [09-12-2020(online)].pdf 2020-12-09
31 3140-CHE-2015-Correspondence-PA-070616.pdf 2016-07-22
31 3140-CHE-2015-OTHERS [09-12-2020(online)].pdf 2020-12-09
32 3140-CHE-2015-FORM 3 [09-12-2020(online)].pdf 2020-12-09
32 3140-CHE-2015-Power of Attorney-070616.pdf 2016-07-22
33 3140-CHE-2015-FER_SER_REPLY [09-12-2020(online)].pdf 2020-12-09
33 Assignment [01-07-2016(online)].pdf 2016-07-01
34 3140-CHE-2015-CLAIMS [09-12-2020(online)].pdf 2020-12-09
34 CERTIFIED COPIES TRANSMISSION TO IB [27-06-2016(online)].pdf 2016-06-27
35 3140-CHE-2015-ABSTRACT [09-12-2020(online)].pdf 2020-12-09
35 Description(Complete) [15-06-2016(online)].pdf 2016-06-15
36 Drawing [15-06-2016(online)].pdf 2016-06-15
36 3140-CHE-2015-Correspondence to notify the Controller [07-05-2021(online)].pdf 2021-05-07
37 Form13_Address of Service Change_31-05-2016.pdf 2016-05-31
37 3140-CHE-2015-Written submissions and relevant documents [24-05-2021(online)].pdf 2021-05-24
38 Other Document [31-05-2016(online)].pdf 2016-05-31
38 3140-CHE-2015-PatentCertificate08-07-2021.pdf 2021-07-08
39 FORM 26-Biological.pdf 2015-06-24
39 3140-CHE-2015-IntimationOfGrant08-07-2021.pdf 2021-07-08
40 Provisional Specification - PCV Patent-MultiV-Formulation- Form 2.pdf 2015-06-24
40 3140-CHE-2015-US(14)-HearingNotice-(HearingDate-11-05-2021).pdf 2021-10-17
41 3140-CHE-2015-FORM-27 [08-05-2025(online)].pdf 2025-05-08

Search Strategy

1 2020-06-1013-50-45E_10-06-2020.pdf

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