Other Process-Related Impurity Analysis
Process-related impurities are those originating from the production process. For biological products, these impurities can be categorized into three main types based on their specific sources: those derived from the cell matrix, those from the culture medium, andthose from downstream processes. Impurities from the cell matrix include proteins, peptides, nucleic acids, and polysaccharides originating from the host organism. Impurities from the culture medium include inducers, antibiotics, and serum. Impurities from downstream processes include enzymes, biochemical treatment reagents, inorganic salts, and solvents. The process-related impurities of different biological products may vary, and it is necessary to establish relevant physicochemical indicators and select appropriate detection methods for analysis based on the actual situation.
BTP Bioscience, based on the dual quality certification system of CNAS/ISO9001, has established seven testing platforms. Combining various analytical technologies such as 2D DIGE, high-resolution mass spectrometry, MALDI TOF, and high-performance chromatography, BTP Bioscience can efficiently and accurately analyze process-related impurities in different biological products. Additionally, BTP Bioscience also provides otherbiological product characterizationrelated services.
BTP Bioscience Biological Product Characterization Service Content
Bilingual Project Report (Chinese/English)
In the technical report, BTP Bioscience will provide you with detailed bilingual (Chinese/English) technical reports, including:
1. Experimental procedures (Chinese and English)
2. Instrument parameters (Chinese and English)
3. Raw data
4. Analysis results of other process-related impurities in biological products
One-stop service for the analysis of other process-related impurities in biological products
You only need to place an order and send samples
BTP Bioscience one-stop service completes: sample processing, instrument analysis, data analysis, and project report
Related services
Product-Related Impurity Analysis
Protein Purity Analysis (Size Exclusion/Reverse Phase Chromatography)
Host Cell Protein (HCP) Residue Analysis Service
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