Services & Solutions
- Contract Manufacturing Services (CMO)
- Contract Research Services (CRO)
- Development and validation of analytical methods
● Development and validation of quality control methods which conform to regulatory filing requirements; and testing services for process control samples as well as products release for GMP manufacturing campaign
• Development and validation of testing methods
• Analytical reports compliant with GLP /GMP regulations
• Validation of equipments and processes
● Testing for raw materials, intermediate, drug substances and finished products
• Protein concentration determination (Lowry assay, A280 , HPLC, etc.)
• Bioactivity test (Cytopathic effect method, Chemiluminescence, ELISA assay)
• Purity test (RP-HPLC, IEX-HPLC, SEC-HPLC, CE-SDS, cIEF, SDS-PAGE)
• Peptide mapping (LC-MS)
• molecular weight determination by mass spectrometry
• Sterility test
• Isoelectric point determination
• Host cell protein assay
• Host cell DNA assay (Hybridization, Fluorescence)
• UV scanning
• Moisture content (Karl Fischer)
• Osmolality measurement
• TOC test
• Subvisible particle analysis
• Bacterial endotoxin test
• pH measurement
