Quality by Design characterization of the perfusion culture process for recombinant FVIII
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Keywords
Quality by Design (QbD)
Process characterization
Design space
Perfusion culture
Recombinant Factor FVIII
Abbreviations
ANOVA
Analysis of Variance
CPPs
Critical Process Parameters
CQAs
Critical Quality Attributes
CS
Coagulation Factor VIII Chromogenic Substrate Assay
DO
Dissolved Oxygen
DOE
Design of Experiment
FMEA
Failure Mode and Effect Analysis
HCD
Host Cell DNA
HCP
Host Cell Protein
HMW rFVIII
High molecular weight rFVIII
IPC
In-Process Control
IVCD
Integrated Viable Cell Density
MCB
Master Cell Bank
MORs
Maximum Operating Ranges
NORs
Normal Operating Ranges
OSC
Coagulation Factor VIII One-Stage Clotting Assay
pCO2
CO2 Partial Pressure
pO2
O2 Partial Pressure
QbD
Quality by Design
rFVIII
Recombinant Factor VIII
RPN
Risk Priority Number
RWCB
Research Working Cell Bank
SD
Standard Deviation
SDM
Scaled-Down Model
Temp.
Temperature
VCD
Viable Cell Density
vWF
von Willebrand factor
WCB
Working Cell Bank
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© 2019 The Authors. Published by Elsevier Ltd on behalf of International Alliance for Biological Standardization.