Host Cell Protein characterization for CHO and E. coli-derived products. 1. One-dimensional gel electrophoresis (SDS-PAGE, Nondenature, Fluorescence stain) 2. Two-dimensional gel electrophoresis (2-D gel, Fluorescence stain) 3. One-dimensional and Two-dimensional Western Blot analysis. 4. Host Cell Protein identification with Mass Spectrometry. 5. Host Cell Protein Risk assessment with Bioinformatics analysis. 6. Impurity analysis program strategy.
Host Cell Protein ELISA analysis with Certificate of Analysis (CofA) for CHO and E. coli HCPs.
Monoclonal antibody drug conformational comparability analysis with ELISA (Avastin; Erbitux; Campath; Rituxin; Humira; Synagis; Herceptin; any other monoclonal antibody drug or drug candidates)
Polyclonal antibody production. 1. Peptide design and synthesis. 2. Peptide and other immunogen conjugation with carrier proteins (KLH or BSA) 3. Antibody production (rabbits) 4. Antibody purification (Protein A or affinity column) 5. Antibody labeling (HRP, Biotin or molecule of interest)
Customer Host Cell Protein ELISA method development and validation: Develop process (or platform)-specific Host Cell Protein ELISA method and validate the method following the corresponding ICH guidelines.
Enzyme assays for over 850 enzymes.
Customer specific biosimilar conformational analysis ELISA development including the design of the antibody coverage, development of ELISA and validation of the method.