TFTB53 - Monoclonal antibodies

Upstream condition that influence downstream process design?

Host cell

cell line

media and raw materials

mode of operation → fed-batch/perfusion

Product quality affected by upstream conditions

Host cell impurities

titer/amount

product variants

• high molecular weight aggregates

• charge variants

• glycan profile

harvest

Centrifugation and depth filters

depth filters train

tangential flow filtration - microfiltration

capture step

Protein A

Viral inactivation/depth filtration

Low pH

Depth filters

polishing step

Ion exchange chromatography

hydrophobic interaction/mixed mode chromatography

viral filtration and ultrafiltration/diafiltration

discrete unit operation

downstream process parameter that impacts drug product quality

process parameters → salt pH temperature

Process reagents

shear rate

agitation rate

drug substance container and filling method