Analytical & Quality Control

EirGenix is a contract development and manufacturing organization performs high quality and cost-effective services supporting our clients in development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing.

Process Development and cGMP Manufacturing

Analytical test is a critical part of the development and manufacturing program. We offer comprehensive in-house analytical service for method development, method transfer, method qualification and validation. Our team is dedicated to GMP production with analysis including raw material testing, in-process testing, lot release testing, stability testing, cleaning (swab / rinse by TOC; conductivity), and environmental monitoring. Available analytical assays/ development include but not limited to:

Identification

• SDS-PAGE
• Western blot
• IEF/CIEF
• Peptide mapping
• HPLC
• CE-Glycan profile
• UPLC-Glycan profile

Quantification

• BCA/Bradford
• A280
• HPLC

Purity

• SEC-HPLC/UPLC
• RP-HPLC
• IEC-HPLC
• PAGE/CE-SDS

Potency/Activity

• ELISA
• Cell base assay

Impurities

• Host cell DNA
• Host cell protein
• ProA residue
• Others

Biological safety

• Endotoxin
• Bioburden
• Microbial enumeration

Analytical method qualification and validation

• Specificity
• Linearity & range
• Accuracy and precision
• LOD/LOQ

Protein Characterization

EirGenix has a well-established team to support our clients in protein characterization. Our main focuses are on primary structure analysis, glycan analysis for site, glycan profile, and ratio, monosaccharide analysis, secondary and higher order structures analysis, and heterogeneity analysis. All protein structure characterization equipment are qualified for service including but not limited to:

Primary structure analysis by HPLC and LC/MS/MS

• Intact MS analysis by high-resolution, accurate-mass spectroscopy
• Peptide map; total sequence analysis by LC/MS/MS
• N-/C-terminal variants
• Disulfide linkages
• Pegylation site determination
• Oxidation, deamidation and other post-modifications

Glycan analysis

• N-, O-linked carbohydrates site and structure by LC/MS/MS
• N-, O-glycan mapping and ratio by HPLC/UPLC
• N-glycan ratio by CE, LC/MS

Secondary and higher order structures

• CD (Circular Dichroism)
• DSC (Differential Scanning Calorimetry)
• Fluorescence Spectrometer

Heterogeneity analysis

• IEF/cIEF
• CIX-HPLC

Monosaccharide analysis by HPIC