Biopharmaceutical Impurities Analysis Service
-
• Native Mass Spectrometry Analysis Services
Native mass spectrometry analysis services enable the characterization and analysis of intact macromolecules, such as proteins and nucleic acids, while preserving their native structural features.Leveraging an advanced mass spectrometry platform, the native mass spectrometry analysis services provided by MtoZ Biolabs mainly include data acquisition and data analysis.
-
Impurity profiling is a specialized analytical technique aimed at identifying, quantifying, and characterizing impurities within pharmaceutical compounds. It provides insights into impurity origins, concentrations, chemical structures, and their potential impacts on drug safety and efficacy. As an essential element in pharmaceutical development and manufacturing, impurity profiling ensures that drug products meet stringent international regulatory standards while maintaining consistent quality across produc
-
Native MS analysis (Native mass spectrometry analysis) is an advanced mass spectrometry (MS) technique used to study the structure and function of proteins and their complexes under near-physiological conditions. MtoZ Biolabs provides native MS analysis service to reveal the molecular weight, binding states, conformational changes, and interactions of proteins in their native state.
-
mRNA HPLC analysis is a critical process based on high-performance liquid chromatography (HPLC) technology, used to evaluate key quality attributes of mRNA, including length distribution, poly(A) tail length and heterogeneity, as well as impurities such as short transcripts and double-stranded RNA. By utilizing anion exchange or reversed-phase columns, mRNA HPLC analysis achieves high sensitivity and high-resolution separation and quantification, providing an accurate sample foundation for downstream mass s
-
• Native Mass Spectrometry Service
Native Mass Spectrometry has revolutionized the way researchers study the structure and function of biological macromolecules. In traditional mass spectrometry, molecules are typically denatured in order to be analyzed, often losing important structural information. However, native mass spectrometry allows for the analysis of proteins and protein complexes in their natural, non-denatured state, preserving their native conformations and biological relevance.
-
• Biopharmaceutical Product-Related Impurities Analysis Service
During the production of bioproducts, it's common to find impurities not only produced in the manufacturing process but also related to the desired products. These product-related impurities typically consist of product variants that do not align functionally with the target product. The most common variants arise from chemical modifications, as well as from the degradation and aggregation of the target product. Protein heterogeneity are often caused by various unexpected post-translational modificati......
-
• Oligonucleotide Purity Analysis Service
Oligonucleotides, including DNA and RNA, have a wide range of uses in gene therapy, biological probes, and diagnosis. For example, DNA can be introduced into immune cells and be modified to express chimeric antigen receptor proteins, which can be used for cell-based immunotherapy. When synthesizing oligonucleotides by solid-phase synthesis techniques, trace impurities may be produced at various stages of the synthesis process.
-
• Biopharmaceutical Process-Related Impurities Analysis Service
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.
-
• 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.
-
• Molecular Size Variation Analysis Service
-
How to order?
