Process-Related Impurity Analysis
In biopharmaceutical engineering and bioproduct manufacturing, the detection and control of process-related impurities are core aspects of product quality management. These impurities mayinclude cell substrates (host cell protein, host cell DNA), cell culture components (inducers, antibiotics, or media components), and impurities generated from downstream processes. These impurities may not only affect the purity and efficacy of the product, but in some cases, may pose potential safety risks.Therefore, obtaining accurate information on process-related impurities is key to ensuring the quality and safety of bioproducts. Efficienthigh-performance liquid chromatography(HPLC), mass spectrometry(MS), nuclear magnetic resonance (NMR), and various electrophoresis techniques, etc.provide powerful tools for the analysis of process impurities,bycombining theseanalytical techniques, it is possible to perform qualitative and quantitative analysis of various impurities generated during the production process.
List of process-related impurities that BTP can detect
Biotech Park Biotech (BTP)throughCNAS/ISO9001 dual quality system certification; the companyutilizes existing bioproduct physicochemical analysis and structural characterization platforms,to provideprocess-related impurity analysis methods, offering comprehensive and precise impurity analysis services, including basic qualitative analysis, in-depth quantitative analysis, and risk assessment. BTP has an experienced team of experts providing efficient, customized solutions to meet various research needs, offering comprehensive support in bioproduct R&D and manufacturing. Feel free to contact us for free consultation to learn more details!
Chinese/English project report
In the technical report, Biotech Park will provide you with a detailed bilingual Chinese and English technical report, including:
1. Experimental procedures (Chinese and English)
2. Relevantexperimentsparameters (Chinese and English)
3. Process-related impurity analysisdetailed information
4. Experimentsimages
5. Raw data
Process-related impurity analysisOne-stop service
You only need to place an order and send samples
Biotech Park's one-stop service completes: sample processing - on-machine analysis - data analysis - project report
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