Analytical & Quality Control
Supporting Process Development Through GMP Manufacturing
Analytical testing is a key part of development and GMP manufacturing. We offer in-house services including method development, transfer, qualification, and validation, as well as testing of raw materials, in-process samples, lot release, stability, cleaning (swab/rinse by TOC, conductivity), and environmental monitoring. Available assays and services include, but are not limited to:
Identification
- SDS-PAGE
- Western blot
- pI by IEF/cIEF/icIEF
- Peptide mapping
- HPLC
Quantification
- BCA/Bradford
- A280
- Protein A titer HPLC
- Titer ELISA
Purity
- SEC-HPLC/UPLC
- RP-HPLC
- IEC-HPLC
- PAGE/CE-SDS
- UPLC N-glycan
Potency/Activity
- ELISA
- SPR
- 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
- Working range
- Accuracy and precision
- LOD/LOQ
Analytical methods
- Excipients quantification
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-translational & chemical modifications
Glycan analysis
- N-, O-linked carbohydrates site by LC/MS/MS
- Glycan mapping and ratio by HPLC/UPLC-FLD
- N-glycan identification by LC/MS
Secondary and higher order structures
- CD (Circular Dichroism)
- DSC (Differential Scanning Calorimetry)
- Intrinsic fluorescence
Heterogeneity analysis
- IEF/cIEF/icIEF
- CIX-HPLC
Monosaccharide analysis by HPIC/HPLC