BIOPHARMA SERVICES

BIOPHARMA SERVICES

Prof. Dr. Hülya AYAR KAYALI, Laboratory Director
Habibe YILMAZ, PhD, Specialist
Melda Zeynep GÜRAY, PhD, Specialist
İdil TİLMENSAĞIR, Chemist
ANALYTICAL SERVICES

Analytical Services offers a wide range analyses required for the biological and physicochemical characterization of biopharmaceuticals to the project partners.

In this facility, development of analytical methods according to protocols in pharmacopoeia (Ph. Eur, USP-NF) and scientific literature; validation of methods in compliance with regulatory guidelines (ICH, EMA, FDA) and analyses of biopharmaceutical products are all performed in GLP compliant laboratories equipped with state-of-the-art instruments.


Structural Characterization
Intact mass (MS*)
Peptide mapping (LC, LC-MS*)
Amino acid sequence (LC-MS/MS*)
PTM analysis (LC-MS/MS*)
Amino acid composition (LC)

Glycan Analyses
N-glycan profiling (LC, CE, LC-MS*)
N-glycosylation site (LC-MS*)
Sialic acid analysis (LC*)

Biological Characterization
Antigen binding (SPR, Western Blot)
FcγR, FcRn, C1q binding (SPR, ELISA)

Purity/Heterogeneity
Aggregation/purity/integrity (LC, CE, SDS-PAGE)
Charge heterogeneity (LC, CE)
Isoelectric point (CE, IEF)

Higher Order Structure Characterization
CD*

General Quality
pH
Osmolarity
Color*
Opalescence*
Protein concentration (A280, BCA, LC, SPR)

Process Related Impurities
Residual Protein A (ELISA)
Host Cell Protein (ELISA)
*Will be available very soon