US 9,808,518 B2
Toxoid, compositions and related methods
Steven Hauser, Swiftwater, PA (US)
Assigned to SANOFI PASTEUR, INC., Swiftwater, PA (US)
Appl. No. 14/776,145
Filed by Sanofi Pasteur, Inc., Swiftwater, PA (US)
PCT Filed Mar. 14, 2014, PCT No. PCT/US2014/029035
§ 371(c)(1), (2) Date Sep. 14, 2015,
PCT Pub. No. WO2014/144567, PCT Pub. Date Sep. 18, 2014.
Claims priority of provisional application 61/790,423, filed on Mar. 15, 2013.
Prior Publication US 2016/0045586 A1, Feb. 18, 2016
Int. Cl. A61K 39/08 (2006.01); A61K 39/00 (2006.01); A61K 39/385 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); C07K 14/33 (2006.01)
CPC A61K 39/08 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); C07K 14/33 (2013.01)] 26 Claims
 
1. A method of producing C. difficile toxoid, the method comprising: incubating purified C. difficile Toxin A under the following conditions:
0.2-0.22% formaldehyde (w/v) at 3.6-4.4° C. for at least 11 days,
0.2-0.22% formaldehyde (w/v) at 13.5-16.5° C. for at least 2.7 days,
0.2-0.22% formaldehyde (w/v) at 22.5-27.5° C. for at least 1.8 days,
0.4-0.44% formaldehyde (w/v) at 3.6-4.4° C. for at least 2.7 days, or
0.4-0.44% formaldehyde (w/v) at 13.5-16.5° C. or 22.5-27.5° C. for at least 0.9 day;
and/or,
incubating purified C. difficile Toxin B under the following conditions:
0.8-0.88% formaldehyde (w/v) at 3.6-4.4° C. for at least 9 days,
0.8-0.88% formaldehyde (w/v) at 13.5-16.5° C. for at least 1.8 days,
0.8-0.88% formaldehyde (w/v) at 22.5-27.5° C. for at least 0.9 day,
0.4-0.44% formaldehyde (w/v) at 13.5-16.5° C. for at least 4.5 days,
0.4-0.44% formaldehyde (w/v) at 22.5-27.5° C. for at least 1.8 days; or,
0.4-0.44% formaldehyde (w/v) at 3.6-4.4° C. for at least 18 days.