MtoZ Biolabs

MtoZ BiolabsModel analysis-of-process-related-impurities - Biopharmaceutical Process-Related Impurities Analysis Service

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In biopharmaceutical engineering and bioproduct production, the detection and control of process-related impurities are the core of product quality management. These impurities may include cell matrix (host residual proteins, host residual DNA), cell cultures (inducers, antibiotics, or culture medium components), and by-products produced in downstream processes. These impurities can not only affect the purity and efficacy of the product but also, in some cases, may pose potential safety risks.
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In biopharmaceutical engineering and bioproduct production, the detection and control of process-related impurities are the core of product quality management. These impurities may include cell matrix (host residual proteins, host residual DNA), cell cultures (inducers, antibiotics, or culture medium components), and by-products produced in downstream processes. These impurities can not only affect the purity and efficacy of the product but also, in some cases, may pose potential safety risks. Therefore, accurate information about process-related impurities is key to ensuring the quality and safety of bioproducts. High-performance liquid chromatography (HPLC), mass spectrometry (MS), nuclear magnetic resonance (NMR), and various electrophoresis techniques provide powerful tools for the analysis of process impurities. By combining these analytical techniques, qualitative and quantitative analysis of various impurities produced during the production process can be performed.

Figure 1. MtoZ Biolabs's Process-Related Impurity Detection List

MtoZ Biolabs uses its existing bioproduct physicochemical analysis platform and structural characterization platform to provide methods for the analysis of process-related impurities, offering comprehensive and accurate impurity analysis services, including basic qualitative analysis as well as in-depth quantitative analysis and risk assessment. MtoZ Biolabs has a team of experienced experts who can provide you with efficient, customized solutions to meet a variety of research needs, providing comprehensive support in bioproduct R&D and production. Free consultation is available to learn more details.


1. Experimental Procedures

2. Relevant Mass Spectrometry Parameters

3. Detailed Information on Process-related Impurity Analysis

4. Mass Spectrometry Images

5. Raw Data


MtoZ Biolabs is an integrate contract research organization (CRO) providing advanced proteomics, metabolomics, bioinformatics, and biopharmaceutical analysis services to researchers in biochemistry, biotechnology, and biopharmaceutical fields. The name of MtoZ represents “mass to charge ratio” in mass spectrometry analysis, as most of our services are provided based on our well-established mass spectrometry platforms. Our services allow for the rapid and efficient development of research projects, including protein analysis, proteomics, and metabolomics programs.

MtoZ Biolabs is specialized in quantitative multiplexed proteomics and metabolomics applications through the establishment of state-of-the-art mass spectrometry platforms, coupled with high-performance liquid chromatography technology. We are committed to developing efficient, and effective tools for addressing core bioinformatics problems. With a continuing focus on quality, MtoZ Biolabs is well equipped to help you with your needs in proteomics, metabolomics, bioinformatics, and biopharmaceutical research. Our ultimate aim is to provide more rapid, high-throughput, and cost-effective analysis, with exceptional data quality and minimal sample.

Email: marketing@mtoz-biolabs.com