QbD |
Quality by Design |
CQAs |
Critical Quality Attributes |
TPQP |
Target Product Quality Profile |
DoE |
Design of Experiments |
PAT |
Process Analytical Technology |
QC |
Quality Control |
HPLC |
High-Performance Liquid Chromatography |
CPPs |
Process Parameters |
ICH |
International Council for Harmonisation |
CMAs |
Critical Material Attributes |
FMEA |
Failure Mode and Effects Analysis |
QMS |
Quality Management Systems |
PROs |
Patient-Reported Outcomes |
RWE |
Real-World Evidence |
PFDD |
Patient-Focused Drug Development |
IVIVC |
In Vitro-in Vivo Correlations |
NIR |
Near-Infrared Spectroscopy |
ADCC |
Alter antibody-Dependent Cellular Cytotoxicity |
HCP |
Host Cell Protein |
SEC |
Size Exclusion Chromatography |
CE |
Capillary Electrophoresis |
PLS |
Partial Least Squares |
RSM |
Response Surface Methodology |
MVA |
Multivariate Analysis |
PCA |
Principal Component Analysis |
RTRT |
Real-Time Release Testing |
MPC |
Model Predictive Control |
CCPs |
Critical Control Points |
ANNs |
Artificial Neural Networks |
DNNs |
Deep Neural Networks |
RL |
Reinforcement learning |
PSD |
Particle Size Distribution |
CM |
Continuous Manufacturing |
OOS |
Out-of-Specification |
CHO |
Chinese Hamster Ovary |
MOI |
Multiplicity of Infection |
HA |
Hemagglutinin |
ATMPs |
Advanced Therapy Medicinal Products |
SLS |
Selective Laser Sintering |
FDM |
Fused Deposition Modeling |
BCS |
Biopharmaceutics Classification System |