ch 1 quiz 1

what have companies defined platform purification processes based on?

a common sequence of unit operations

what is the order of the frequently used platform purification for mAbs?

cell culture, centrifuge, protein A, cation exchange chromatography, anion exchange chromatography, virus filter, UF/DF

the conditioned medium is first clarified by _____, followed by _____

centrifugation, followed by depth filtration

protein A chromatography allows for?

direct product capture from the centrate

what does protein A chromatography achieve?

excellent purification and significant concentration of the product

what does low pH elution from protein A allow for?

accomplishes virus inactivation

what are the two chromatographic polishing steps used for

reducing host cell/medium-derived and purification process-related impurities

what are the two polishing steps?

anion exchange chromatography (in flow through mode) and cation exchange chromatography

what is the occasional uses for polishing

ceramic hydroxyapatite chromatography and hydrophobic interaction chromatography (HIC)

what do VRF (virus removal filtration) and ultrafiltration/diafiltration (uf/df) do

formulate and concentrate product, which is the bulk drug substance

what have several companies recently introduced to the platform

adding detergent to the process pool to enable virus inactivation

the variables that may be influenced by product or feed stream variations

dynamic binding capacity, optimal composition of column wash solution, and elution conditions

where do variations in these process parameters arise from

differences in the affinity of protein A for the mAb, steric hindrance among molecules, and variations in impurity levels and species in feed stream

what are the common variables for the ion exchange polishing steps

column loading and solution compositions and wash and elution compositions

choices that must be made regarding investment in early stage process development

tailored and generic conditions

example of tailored approach

use of high throughout screening to define unique operating conditions

a more flexible step would be what

to use a single counterion concentration