C - Chemistry – Metallurgy – 07 – K
Patent
C - Chemistry, Metallurgy
07
K
C07K 16/00 (2006.01)
Patent
CA 2722348
The invention relates to methods for manufacturing drug products comprising at least two distinct members of a polyclonal protein, for example a polyclonal antibody, where each distinct member is expressed by a separate population of cells. The methods involve at least an initial step in which the cell populations expressing the distinct members of the polyclonal protein are cultured separately. The individual cell populations, or proteins expressed by the individual cell populations, are combined at a later point of the upstream or downstream processing to result in a single drug product comprising the distinct members of the polyclonal protein.
La présente invention concerne des procédés pour fabriquer des produits pharmaceutiques comprenant au moins deux éléments distincts dune protéine polyclonale, par exemple un anticorps polyclonal, où chaque élément distinct est exprimé par une population de cellules séparée. Les procédés mettent en uvre au moins une étape initiale dans laquelle les populations de cellules exprimant les éléments distincts de la protéine polyclonale sont cultivées séparément. Les populations de cellules individuelles, ou les protéines exprimées par les populations de cellules individuelles, sont combinées à un stade ultérieur du traitement amont ou aval pour conduire à un produit pharmaceutique unique comprenant les éléments distincts de la protéine polyclonale.
Graversen Jonas Heilskov
Muller Christian
Nielsen Lars Soegaard
Tolstrup Anne Bondgaard
Weilguny Dietmar
Borden Ladner Gervais Llp
Symphogen A/s
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