Patent ID: 9636411
Date: 2017-05-02
CPC Classifications: A61K,A61P,C08G

Claim:
1. A process of manufacture for preparing batches of a poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate comprising: polymerizing a compound of Formula (A) to form a polymer having recurring units of Formula (I), wherein R forming the alkali metal salt of the recurring unit of Formula (I); reacting the alkali metal salt of the recurring unit of Formula (I) with a compound of Formula (B) to form a polymer having recurring units of Formula (II), wherein each R removing the R reacting an anticancer drug with a portion of the recurring units of Formula (III) to form the poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate, wherein the poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate comprises recurring units of Formula (IV) and recurring units of Formula (V): wherein: each R each R wherein at least 3 batches of poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate are prepared; wherein each batch provides an amount of the poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate greater than or equal to about 300 grams; and wherein each batch of poly(L-γ-glutamyl-glutamate)-anticancer drug conjugate has one or more characteristics selected from a weight average molecular weight within ±10 kDa from each other batch, a polydispersity in the range of 1.0 to 2.0 and an endotoxin content <0.25 EU/mg.