In according to the FDA “well characterized biological product” concept and ICH Q6B guidelines, ProtTech provides following services for the characterization and confirmation of therapeutic proteins: SDS-Polyacrylamide gel electrophoresis (SDS-PAGE), Native polyacrylamide gel electrophoresis (Native –PAGE) and isoelectric focusing (IEF).

SDS-PAGE: The estimated MWt and purity of test protein will be reported.

Native-PAGE: Possible protein aggregation will be analyzed and reported.

IEF: The isoelectric point of test protein will be reported. The presence and ratio of the heterogeneous forms due to post-transnational modifications, such as acetylation and deamidation, will be assayed and reported.

• Protein Mixture Quantitation & Impurity Analysis

• Peptide Mapping

• Disulfide Bond Analysis

• Glycosylation Analysis

• Intact Molecular Weight Measurement

• N-terminal and C-terminal Sequencing

• Liquid Chromatographic Analysis

• Colony Selection

• Antibody Epitope Mapping

• Identifying Antibody Molecular Targets

• De Novo Sequencing of mAb

• Software for Characterizing Therapeutic Proteins

• Submit A Request