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Analytical & Quality Control Services
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:
- SDS-PAGE
- Western blot
- IEF/CIEF
- Peptide mapping
- HPLC
- CE-Glycan profile
- UPLC-Glycan profile
- BCA/Bradford
- A280
- HPLC
- SEC-HPLC/UPLC
- RP-HPLC
- IEC-HPLC
- PAGE/CE-SDS
- ELISA
- Cell base assay
- Host cell DNA
- Host cell protein
- ProA residue
- Others
- Endotoxin
- Bioburden
- Microbial enumeration
- Specificity
- Linearity & range
- Accuracy and precision
- LOD/LOQ
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:
- SDS-PAGE
- Western blot
- IEF/CIEF
- Peptide mapping
- HPLC
- CE-Glycan profile
- UPLC-Glycan profile
- BCA/Bradford
- A280
- HPLC
- SEC-HPLC/UPLC
- RP-HPLC
- IEC-HPLC
- PAGE/CE-SDS
- ELISA
- Cell base assay
- Host cell DNA
- Host cell protein
- ProA residue
- Others
- Endotoxin
- Bioburden
- Microbial enumeration
- Specificity
- Linearity & range
- Accuracy and precision
- LOD/LOQ
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:
- 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
- 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
- CD (Circular Dichroism)
- DSC (Differential Scanning Calorimetry)
- Fluorescence Spectrometer
- IEF/cIEF
- CIX-HPLC