Process Assumptions
Upstream process performance was assumed to improve from a previous
report of laboratory-scale operation (Corbin et al., 2016) in two major
categories, cell growth and rrBChE expression. Table 1 displays recently
obtained values at the laboratory-scale along with the projected values
at manufacturing scale to be used for this process model. A detailed
justification of the projected values can be found in Supplementary
Information.
The downstream processing scheme consists of each of the major steps
described in the previous report of laboratory-scale downstream process
development (Corbin et al., 2018). Current laboratory-scale and
projected modeling values of rrBChE recovery are shown in Table 2. A
detailed justification of the projected values can be found in
Supplementary Information.
Clean-in-Place (CIP) assumptions were developed using working process
knowledge and literature (Bremer & Seale, 2010; Chisti & Moo-Young,
1994; Lydersen, D’Elia, & Nelson, 1994). Details of the procedures used
in the modeling can be found in Table S1 of Supplementary Information.