Wyeth

Pfizer Corporation

Ling Chu

Mark Edward Ruppen

Justin Keith Moran

John W Simpson

Wei-Qiang Willie Sun

Yonghui Yuan

James Patch

Annaliesa Sybil Anderson

Jianxin Gu

Avvari Krishna Prasad

Jin-Hwan Kim

Robert G K Donald

Jason Arnold Lotvin

Wei Chen

Srinivas Kodali

Nishith Merchant

Suddham Singh

Laurent Oliver Chorro

Rosalind Pan

Scott Ellis Lomberk

Pamela S Fink

Karen Kiyoko Takane

Pamela Fink Charbonneau

In one aspect, the invention relates to an immunogenic composition comprising modified O-polysaccharide molecules derived fromlipopolysaccharides and conjugates thereof. Multivalent vaccines may be prepared by combining two or more monovalent immunogenic compositions for differentserotypes. In one embodiment, the modified O-polysaccharide molecules are produced by a recombinant bacterium that includes a wzz gene.

compositions and methods thereof

A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellularlysate broth is described. Ultrafiltering and diafiltering a clarifiedlysate followed by pH adjustment to less than 4.5, preferably about 3.5, precipitated at least 98% of the protein in the solution without seriously affecting polysaccharide yield. Furthermore, following ultrafiltration and diafiltration and acidification to a pH of less than 4.5, filtration using activated carbon precipitated at least 90% of remaining protein without seriously affecting polysaccharide yield. Exemplary, non-limiting S. pneumoniae serotypes that can be purified using the shortened process of the invention are 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In one embodiment, thecells are lysed using deoxycholate sodium (DOC), while in another embodiment the lytic agent is a non-animal derived lytic agent such as N-lauryl sarcosine sodium (NLS).

[object Object]

A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellularlysate broth is described. Ultrafiltering and diafiltering a clarifiedlysate followed by pH adjustment to less than 4.5, preferably about 3.5, precipitated at least 98% of the protein in the solution without seriously affecting polysaccharide yield. Furthermore, following ultrafiltration and diafiltration and acidification to a pH of less than 4.5, filtration using activated carbon precipitated at least 90% of remaining protein without seriously affecting polysaccharide yield. Exemplary, non-limitingserotypes that can be purified using the shortened process of the invention are 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In one embodiment, thecells are lysed using deoxycholate sodium (DOC), while in another embodiment the lytic agent is a non-animal derived lytic agent such as N-lauryl sarcosine sodium (NLS).

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Suffern, NY, United States of America

Ling Chu