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B
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U
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X
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A
Active ingredient (or active substance)
ANTIBODY
ANTIGEN
ANTIGEN DETERMINANT
ANTIGENITCITY
AVIDITY
B
BACTERIOPHAGE
BACULOVIRUS
BATCH CULTURE
BINDING
BIOACTIVITY
BIOAVAILABILITY
BIOEQUIVALENCE
BIOLOGICAL DRUGS
BIOPHARMACEUTICAL
BIOPROCESSING
BioSim
BIOSIMILAR
BIOSIMILARITY
BIOTECHNOLOGY
C
CBER
CELL BANK
CELL CULTURE
CELL HARVESTING
CELL LINE
cGMP
CHIMERIC TRANSGENE
CHMP
CLINICAL STUDY TRIAL
CLONE
COMPARABILITY
E
EMA
EXTRAPOLATION
F
FDA
FEED
FINGERPRINT-LIKE
FORMULATION
Fucosylation
G
GENE TRANSFER
GENETIC ENGINEERING
GLYCOSYLATION
GMP
H
HAPTEN
HIGH-AFFINITY ANTIBODY
HLA
I
IMMUNOGENICITY
INNOVATIVE REFERENCE DRUG
INTERCHANGEABILITY
M
Mab
MANUFACTURING SCALE PRODUCTION
Marketing authorisation
MCB (MASTER CELL BANK)
MEDIA
MONOCLONAL ANTIBODY (MAB)
O
ORIGINATOR COMPANY
OUTSOURCING ACTIVITIES
P
Patent
PERFORMACE QUALIFICATION
PHARMACODYNAMIC TEST
PHARMACOKINETIC TEST
PHARMACOVIGILANCE
Q
QUALITY
R
Risk management system
S
SIMILARITY
SINGLE-USE TECHNOLOGY
SUBSTITUTION
T
TRACEABILITY