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Analytical & QC
We perform Quality Control testing on all incoming product/raw material. In addition, we conduct in-process testing, including titer assays, pH, OD, dCO2, viable cell density, viability, wet cell weight, dry cell weight, bioburden, endotoxin etc. as appropriate for the process. Many of these tests can be validated for the custom product that is being manufactured in our manufacturing facility.
Analytical and Quality Control group provides the following services:
- Analytical development and validation
- Pharmacopoeia testing and cGMP compliant Quality Control
- Analyses of raw materials, in-process, intermediates and final API's
- Protein characterization
- Environmental monitoring
Microbiological Analysis
- Identification
- Purity
- Plasmid copy number
- Plasmid retention/stabilit
- TOC
Bioassays
- To determine the bioefficacy
Biochemical Analysis
- Identity of protein by immunological means (Western blot, ELISA)
- RP HPLC
- IEX/SEC
- SDS-PAGE & IEF
- Protein quantification (Bradford, BCA, A280)
- Mass spectrometry
Biosafety Testing
- Sterility
- Endotoxin
- Host cell protein
- Host cell DNA
- Process and Product related impurities
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