Analytical & Quality Control
Supporting Process Development Through GMP Manufacturing
Biologics analytical development services and quality control testing support biopharmaceutical process development and GMP manufacturing. EirGenix provides in-house analytical method development, transfer, qualification, and validation, along with raw material, in-process, lot release, and stability testing.
Additional services include cleaning validation sample testing (TOC and conductivity analysis of swab and rinse samples) and environmental monitoring. Available assays and services include:
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
Excipient analysis
- Excipients quantification
Protein Characterization
EirGenix provides protein characterization services to support biologics development, process development, and regulatory submissions. Our capabilities cover primary structure analysis, glycan profiling and glycosylation site analysis, monosaccharide analysis, secondary and higher-order structure analysis, and heterogeneity analysis.
The following analyses are supported by qualified analytical equipment:
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