公开(公告)号：EP3250696B1

公开(公告)日：2024-06-05

申请号：EP16708776.6

申请日：2016-01-29

IPC分类号： C12N15/867 ,  C12N7/02

CPC分类号： C12N2740/1305120130101 ,  C12N7/00

公开(公告)号：EP4379047A3

公开(公告)日：2024-08-07

申请号：EP24170763.7

申请日：2016-01-29

申请人： MockV Solutions LLC

发明人： CETLIN, David ,  DHAR, Arun

IPC分类号： C12N15/867 ,  C12N7/02 ,  C12Q1/70 ,  G01N33/15 ,  G01N33/569

CPC分类号： C12N2740/1305120130101 ,  C12N7/00 ,  C12N2740/1002320130101 ,  C12Q1/702 ,  G01N33/15 ,  G01N33/56983 ,  C12N7/02 ,  C12N2740/1005120130101 ,  C12N15/86

摘要： The present invention relates to a stock solution (RLP Stock Solution) of mammalian cell-endogenous retrovirus like particles (RLP), a method of preparing a RLP stock solution, a kit containing a RLP stock solution, and a method of quantifying the amount of RLP removed from a solution. An RLP stock solution will contain a high concentration of RLP and an extremely low amount of any therapeutic proteins of interest. In some instances, an RLP stock solution will contain a very low amount of natural mammalian host cell protein (HCP) and DNA. The method of preparing a RLP stock solution will consist of the production of RLP during fermentation or cell culturing and the subsequent purification of RLP from fermentation or cell culture solution. The kit will comprise at least two containers. One container comprised of RLP stock solution and one comprised of PCR primers or one or more antibodies. The method of quantifying RLP comprises the steps of adding RLP stock solution to an in-process solution containing a recombinant therapeutic of interest, processing the resulting solution through a bioprocess purification technique, and then quantifying the amount of RLP removed.

公开(公告)号：EP3732296B1

公开(公告)日：2024-06-19

申请号：EP18827082.1

申请日：2018-12-20

IPC分类号： C12N15/86 ,  C12N7/00 ,  C12M3/00 ,  C12M1/00

CPC分类号： C12N7/00 ,  C12N2740/1305120130101 ,  C12N2740/1605120130101 ,  C12N15/86 ,  C12N2740/1505120130101 ,  B01D15/3809 ,  C12N5/0636

公开(公告)号：EP4379047A2

公开(公告)日：2024-06-05

申请号：EP24170763.7

申请日：2016-01-29

申请人： MockV Solutions LLC

发明人： CETLIN, David ,  DHAR, Arun

IPC分类号： C12N7/02

CPC分类号： C12N2740/1305120130101 ,  C12N7/00

摘要： The present invention relates to a stock solution (RLP Stock Solution) of mammalian cell-endogenous retrovirus like particles (RLP), a method of preparing a RLP stock solution, a kit containing a RLP stock solution, and a method of quantifying the amount of RLP removed from a solution. An RLP stock solution will contain a high concentration of RLP and an extremely low amount of any therapeutic proteins of interest. In some instances, an RLP stock solution will contain a very low amount of natural mammalian host cell protein (HCP) and DNA. The method of preparing a RLP stock solution will consist of the production of RLP during fermentation or cell culturing and the subsequent purification of RLP from fermentation or cell culture solution. The kit will comprise at least two containers. One container comprised of RLP stock solution and one comprised of PCR primers or one or more antibodies. The method of quantifying RLP comprises the steps of adding RLP stock solution to an in-process solution containing a recombinant therapeutic of interest, processing the resulting solution through a bioprocess purification technique, and then quantifying the amount of RLP removed.