公开(公告)号：EP2436700A1

公开(公告)日：2012-04-04

申请号：EP11194173.8

申请日：2008-03-20

申请人： Wyeth LLC

发明人： Yuan, Yonghui ,  Ruppen, Mark ,  Sun, Wei-Qiang ,  Chu, Ling ,  Simpson, John ,  Patch, James ,  Fink Charbonneau, Pamela ,  Moran, Justin K.

IPC分类号： C08B37/00 ,  A61K47/48

CPC分类号： A61K39/092 ,  A61K39/00 ,  A61K47/646 ,  A61K2039/6087 ,  A61K2039/62 ,  C07H1/08 ,  C08B37/00 ,  C08B37/0003 ,  C12P19/04

摘要： A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellular Streptococcus pneumoniae lysate broth is described. Ultrafiltering and diafiltering a clarified S. pneumoniae lysate 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, the Streptococcus pneumoniae cells 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).

摘要翻译： 描述了从细胞肺炎链球菌裂解液肉汤制备含有基本上纯化的荚膜多糖的溶液的缩短方法。 超滤并透析澄清的肺炎链球菌裂解物，然后pH调节至小于4.5，优选约3.5，在溶液中沉淀至少98％的蛋白质，而不会严重影响多糖产量。 此外，超滤和渗滤并酸化至pH小于4.5之后，使用活性炭过滤沉淀至少90％的剩余蛋白质，而不会严重影响多糖产量。 可使用本发明缩短方法纯化的示例性非限制性肺炎链球菌血清型是1,4,5,6A，6B，7F，9V，14,18C，19A，19F和23F。 在一个实施方案中，使用脱氧胆酸钠（DOC）裂解肺炎链球菌细胞，而在另一个实施方案中，溶解剂是非动物来源的溶解剂，例如N-月桂基肌氨酸钠（NLS）。

公开(公告)号：EP3406635A1

公开(公告)日：2018-11-28

申请号：EP18177128.8

申请日：2008-03-20

申请人： Wyeth LLC

发明人： Yuan, Yonghui ,  Ruppen, Mark ,  Sun, Wei-Qiang ,  Chu, Ling ,  Simpson, John ,  Patch, James ,  Fink Charbonneau, Pamela ,  Moran, Justin K.

IPC分类号： C08B37/00 ,  A61K47/64 ,  C12P19/04

CPC分类号： A61K39/092 ,  A61K39/00 ,  A61K47/646 ,  A61K2039/6087 ,  A61K2039/62 ,  C07H1/08 ,  C08B37/00 ,  C08B37/0003 ,  C12P19/04

摘要： A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellular Streptococcus pneumoniae lysate broth is described. Ultrafiltering and diafiltering a clarified S. pneumoniae lysate 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.

公开(公告)号：EP2436700B8

公开(公告)日：2018-08-01

申请号：EP11194173.8

申请日：2008-03-20

申请人： Wyeth LLC

发明人： Yuan, Yonghui ,  Ruppen, Mark ,  Sun, Wei-Qiang ,  Chu, Ling ,  Simpson, John ,  Patch, James ,  Fink Charbonneau, Pamela ,  Moran, Justin K.

IPC分类号： C08B37/00 ,  A61K47/64 ,  C12P19/04

CPC分类号： A61K39/092 ,  A61K39/00 ,  A61K47/646 ,  A61K2039/6087 ,  A61K2039/62 ,  C07H1/08 ,  C08B37/00 ,  C08B37/0003 ,  C12P19/04

摘要： A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellular Streptococcus pneumoniae lysate broth is described. Ultrafiltering and diafiltering a clarified S. pneumoniae lysate 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, the Streptococcus pneumoniae cells 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).

公开(公告)号：EP2436700B1

公开(公告)日：2018-06-20

申请号：EP11194173.8

申请日：2008-03-20

申请人： Wyeth LLC

发明人： Yuan, Yonghui ,  Ruppen, Mark ,  Sun, Wei-Qiang ,  Chu, Ling ,  Simpson, John ,  Patch, James ,  Fink Charbonneau, Pamela ,  Moran, Justin K.

IPC分类号： C08B37/00 ,  A61K47/64 ,  C12P19/04

CPC分类号： A61K39/092 ,  A61K39/00 ,  A61K47/646 ,  A61K2039/6087 ,  A61K2039/62 ,  C07H1/08 ,  C08B37/00 ,  C08B37/0003 ,  C12P19/04

摘要： A shortened process for producing a solution containing substantially purified capsular polysaccharides from a cellular Streptococcus pneumoniae lysate broth is described. Ultrafiltering and diafiltering a clarified S. pneumoniae lysate 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, the Streptococcus pneumoniae cells 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).