感谢ygfyzy参与讨论．
- X; H, g) u0 y7 yroadman 　说的　“融浆”我联想到　培养基了
! F: O7 Q) E$ V3 P4 H6 J% y现在ygfyzy　的意思是　混合（收集）　7 F9 @3 q$ U& B/ g. E) f: V
在生物制品印度官网下的　Guidance for Industry 里的3.2.S.2 manufacturing process for Drug substance.
) o+ g5 B* \& g2 `5 A原文是，Rather then providing separate flow diagrams for the fermentation and purification processes, the applicant may consider providing an overall process flow diagram, including the relevant information described under each step below. e.g. in-process control testing, size and scale of equipment, batch size, pooling, hold times, and method of transfer. An explanation of the batch numbering system, including information regarding any pooling of harvests or intermediates and batch size or scale should be provided. Since pooling may occur at more than one step, it may be more appropriate to describe the batch size and scale under the respective step(s), both within the flow diagram(s) and in the detailed description.* h( L9 K, j6 g! {# `, \: u
里面的pooling
2 `9 Y2 [8 B! \7 }! Z5 n7 Ocaric 发表于 2010-1-15 09:22 AM