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Bio B2BEirGenix, Inc. 〉Analytical Capability and Protein Characterization

Analytical Capability and Protein Characterization

EirGenix offers comprehensive in-house analytical service for method development, method qualification, comparability testing, in-process testing, lot release testing, and stability testing, as well as protein characterization.

- Analytical support and data interpretation to guide the development of CQAs throughout the development process
- Method development and optimization strategies
- Product specific methods to measure process related performance
- Standard operating procedures (SOPs) as quality control (QC)
- Platform method technologies (more cost effective)
- Phase appropriate method qualification and validation services
- Potency, efficacy and safety profiling of biopharmaceutical product for regulatory submission and market release

Analytical Development / Qualification / Validation (AMD, AMQ, AMV) and Quality Control (QC) for Process Development and cGMP Manufacturing
- Identification: SDS-PAGE, Western blot, IEF/cCIEF, Peptide mapping, HPLC, CE-Glycan profile, UPLC-Glycan profile
- Quantification: BCA/Bradford, A280, purity, SEC-HPLC, RP-HPLC, PAGE
- Potency/Activity: ELISA, cell based assays
- Impurities: Host cell DNA, Host cell protein, ProA residue, others
- Biological safety: Endotoxin, Bioburden, Microbial enumeration

Protein Characterization
- Intact MS analysis by high-resolution, accurate-mass spectrometry
- Peptide maps
- Total sequence analysis by LC/MS/MS
- N-/C-terminal variants
- Disulfide linkages/oxidation/deamidation/other posttranslational modifications
- N-, O-linked carbohydrate site and structure by LC/MS/MS
- N-, O -glycan mapping and ratio by HPLC/UPLC
- N-glycan ratio by CE
- Monosaccharide analysis by HPIC
- Secondary and higher order structures by CD, DSC, Fluorescence
- Heterogeneity analysis by IEF/cIEF and CIX-HPLC
Service procedure
Initial Contact -> Sign CDA -> Clients fill in CMO/CDMO Request Form -> Eirgenix provides quotation with timeline -> Sign Contract
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