Testing along the mAb process
Engage SGS experts early in your monoclonal antibody program. From discovery through
PK/PD BIOANALYSIS
CELL LINE GENERATION
PROCESS OPTIMIZATION
ENGINEERING RUN
GMP MANUFACTURING
FORMULATION (FILL & FINISH)
CLINICAL STUDIES
monoclonal antibody development process
to market entry, we simplify complexity,
minimize technical and communication barriers, and significantly accelerate regulatory approval.
Our clients can rely on SGS global analytical capabilities and dedicated expertise to accelerate their mAbs project
CELL BANK TESTING • Microbiological • Identity • Viral safety testing • Genetic stability
ANALYTICAL DEVELOPMENT • Methods to monitor critical Quality Attributes
ANALYTICAL DEVELOPMENT • Methods in line with ICH Q14
TRIAL PHASES I, II & III • Biomarker development • Validation of bioanalytical methods
GMP VALIDATION • Methods in line with ICH Q2(R2)
STABILITY TRIALS • Drug Substance • Drug Product
BIOSAFETY
In vitro adventitious virus assays • Endotoxins •
• TEM • Retroviruses detection assays
Mycoplasma (culture + qPCR) • Sterility / Bioburden
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