Analytical

Analytical

Our scientists possess in-depth knowledge for choosing ideal solutions to aid your product development and investigative studies. The broad BNS assay repertoire is suitable for process effect screening study, process optimization, comparability studies, defining Critical Quality Attributes for in-process and release testing, and final product stability evaluation.

Analytical Assays

Titer

HPLC (ProA/ProL affinity, RP, SEC)

Octet RED96 using various type of BLI sensors

Quantitative ELISA

BCA total protein assay

A280 by SoloVPE for purified proteins

Purity Assay

Product related impurity

Size exclusion HPLC, HIC HPLC (aggregation/fragmentation)

CEX HPLC, icIEF, cIEF, CZE (Charge variants)

CE-SDS, SDS-PAGE (IgG purity)

Peptide mapping, LC/MS

Process impurity (safety)

HCP/ProA ELISA

Endotoxin level

Mycoplasma testing

Sterility Testing

Particle counts

Osmolarity

Structure Assay

Glycan profile

Total released N-glycan profile (2AB labelling/HILIC HPLC/LC/MS)

Total sialic acid content (DMB labeling/RP HPLC)

Sialylated N-glyan profile (2AB labelling/AEX HPLC)

Primary Structure (LC/MS)

Intact proteins MW

Peptide mapping

Amino acid sequence confirmation

N-terminus and C-terminus amino acid

Disulfide linkage, glycosylation site(s)

Amino Acid Analysis

Physical Property

DSC

CD

FTIR

Potency

Binding assay

KD by Octet

ELISA

Flow cytometry

Cell based Potency Assay

ADCC

CDC

Cell Proliferation (e.g. TNF-alpha mediated cytotoxicity)

Intracellular Signal Transduction Indicating Pathway

Assay Development and Qualification per Mechanism of Action (MoA) for a product candidate