Genovior provides services in analytical method development, qualification, and validation. The method development team works closely with process and formulation development teams to create validated analytical methods. All analytical method qualification and validation relating to raw materials, IPC, and final product releases follow ICH guidelines to comply with US-FDA and EMA requirements. Stability test program is performed according to ICH and WHO guidelines to meet the US-FDA, EMA, and WHO requirements.
- Cleaning analysis: TOC, Bioburden, product specific assay-HPLC, ELISA
- Stability test: Follow ICH guidance, WHO guideline, and USFDA guideline
- Analytical method validation: comply with ICH guideline Q2 and US-FDA guideline
Analytical Method Development, Qualification, and Validation Service
- Analysis for protein/peptide APIs and drugs
- Physiochemical assay: Appearance, pH, Osmolarity, Particle size distribution, Zeta potential, Particle matter, Water content, Uniformity assay
- Identity assay: SDS PAGE, Tricine SDS PAGE, cSDS, cIEF, HPLC, Peptide mapping, Western Blot
- Strength: HPLC, BCA, Bradford, UV protein concentration assay
- Potency assay: binding ELISA, cell based assay, cAMP assay, drug load
- Non-product related impurity profile: Host DNA residual assay, Host protein residual assay, GC solvent residual assay, ICP-OES heavy metal assay
- Product related purity and impurity assay: SEC HPLC, Reverse phase HPLC, Ion exchange HPLC, SDS PAGE
- Glycan profile: Monosaccharide composition, N-linked oligosaccharide profile
- Safety assay: Sterility, Microbial enumeration, Specified microorganisms assay, Bacterial endotoxin
- Cleaning analysis: TOC, Bioburden, product specific assay-HPLC, ELISA
- Stability test: Follow ICH guidance, WHO guideline, and USFDA guideline
- Analytical method validation: comply with ICH guideline Q2 and US-FDA guideline
Analytical Contract Service: Compliance with PIC/S GMP (cGMP, EU GMP)
- Raw material analysis
- Identification, Heavy metal, Water content, specific rotation, Limit assay, Assay, and etc.
- Pharmaceutical water system monitor analysis: pH, Conductivity, Bioburden, TOC, Bacterial endotoxin, and etc.
Analytical Equipment
- FTIR
- HPLC
- ICP-OES
- GC-FID
- TOC
- Capillary electrophoresis system
- Threshold immunoassay system
- Microplate reader
- Electrophoresis system and gel image system
- Particle size distributor and Zeta potential detector
- Particle counter
- Karl Fischer Moisture Titrator
- Potentiometric Titrator
- Osmometer
- Analytical balance
- pH meter
- Conductivity meter
- Sterility test system
- Vacuum oven
- Ashing Furnace
- CO2 Incubator
- Microbial incubator
- Stability test oven