Additional Process-Related Impurities Analysis Service

Process-related impurities refer to impurities originating from the production process. Bioproducts' process-related impurities can be categorized into three main types based on their specific sources: those originating from the cell matrix, those from the culture medium, and those from downstream processes. Impurities originating from the cell matrix include proteins, peptides, nucleic acids, and polysaccharides derived from the host organism. Impurities from the culture medium include inducers, antibiotics, and serum, etc. Impurities from downstream processes include enzymes, biochemical treatment reagents, inorganic salts, and solvents, etc. The process-related impurities of different bioproducts may vary, and it is necessary to develop relevant physicochemical indicators and choose appropriate detection methods for analysis based on the actual situation.

 

MtoZ Biolabs combines various analytical techniques such as 2D DIGE, high-resolution mass spectrometry, MALDI TOF, and HPLC to efficiently and accurately analyze the process-related impurities of different bioproducts. In addition, MtoZ Biolabs also provides other bioproduct characterization-related services.

 

Services at MtoZ Biolabs

 



Deliverables

In the technical report, MtoZ Biolabs will provide you with detailed technical information, including: 

1. Experimental Procedures

2. Related Instrument Parameters

3. Raw Data

4. Analysis Results of Other Process-Related Impurities in Bioproducts