mAbxience | Glossary

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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