mAbxience | Glossary

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T

TRACEABILITY

S

SUBSTITUTION

SINGLE-USE TECHNOLOGY

SIMILARITY

R

Risk management system

Q

QUALITY

P

PHARMACOVIGILANCE

PHARMACOKINETIC TEST

PHARMACODYNAMIC TEST

PERFORMACE QUALIFICATION

Patent

O

OUTSOURCING ACTIVITIES

ORIGINATOR COMPANY

M

MONOCLONAL ANTIBODY (MAB)

MEDIA

MCB (MASTER CELL BANK)

Marketing authorisation

MANUFACTURING SCALE PRODUCTION

Mab

I

INTERCHANGEABILITY

INNOVATIVE REFERENCE DRUG

IMMUNOGENICITY

H

HLA

HIGH-AFFINITY ANTIBODY

HAPTEN

G

GMP

GLYCOSYLATION

GENETIC ENGINEERING

GENE TRANSFER

F

Fucosylation

FORMULATION

FINGERPRINT-LIKE

FEED

FDA

E

EXTRAPOLATION

EMA

C

COMPARABILITY

CLONE

CLINICAL STUDY TRIAL

CHMP

CHIMERIC TRANSGENE

cGMP

CELL LINE

CELL HARVESTING

CELL CULTURE

CELL BANK

CBER

B

BIOTECHNOLOGY

BIOSIMILARITY

BIOSIMILAR

BioSim

BIOPROCESSING

BIOPHARMACEUTICAL

BIOLOGICAL DRUGS

BIOEQUIVALENCE

BIOAVAILABILITY

BIOACTIVITY

BINDING

BATCH CULTURE

BACULOVIRUS

BACTERIOPHAGE

A

AVIDITY

ANTIGENITCITY

ANTIGEN DETERMINANT

ANTIGEN

ANTIBODY

Active ingredient (or active substance)