Why SGS: Complete mAbs Project Support
QC & stability (DS, DP, raw materials)
Characterization
Biosafety
Bioanalysis and clinical
STRUCTURAL CHARACTERIZATION • Composition, sequencing, PTMs HIGHER ORDER STRUCTURE • Secondary, tertiary and aggregates FUNCTIONAL CHARACTERIZATION • Ligand binding and cell-based technologies IMPURITY IDENTIFICATION • Product- & process-related impurities
RELEASE TESTING • Compendial, bespoke ID tests • Potency and function MICROBIOLOGY
V IRUS DETECTION ASSAYS • In-vitro, qPCR, TEM CELL IDENTITY & CHARACTERIZATION • DNA fingerprinting, Sanger sequencing GENETIC STABILITY • Southern blot, DNA sequencing (NGS)
ACROSS DRUG DEVELOPMENT PROCESS • From discovery pharmacology to late clinical stages REGULATORY TOXICOLOGY PRECLINICAL AND CLINICAL • Pharmacokinetics (PK) • Immunogenicity (ADA, Nab) • Pharmacodynamics (Cellular/Soluble Biomarkers)
• Sterility, bioburden, endotoxin QUANTITATIVE IMPURITY ANALYSES • Product- and process-related impurities STABILITY TESTING • Accelerated, standard
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