Biopharmaceutical Impurities Analysis Service

• • mRNA HPLC Analysis Service

  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

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• • Metal Content Analysis Service

  Metal content analysis is a technique for detecting and quantifying concentration of metal elements in samples, crucial for ensuring the efficacy and safety of bioproducts during their development and manufacturing. Common methods include atomic absorption spectroscopy (AAS), X-ray fluorescence (XRF), and inductively coupled plasma mass spectrometry (ICP-MS). AAS, a straightforward and cost-effective method, analyzes metal content by combusting the sample and measuring the absorbance of specific elements

• • Protein Content Analysis Service

  The analysis of protein content in bioproducts is a principal method for assessing bioproduct quality and constitutes a significant aspect of bioproduct quality standards. Typically, the analysis employs chemical or physical methods, including titration, spectroscopy, and chromatography. Titration offers simplicity and accuracy. Spectroscopy provides rapidity and high sensitivity. Chromatography excels in both sensitivity and specificity.

• • Host Cell Protein (HCP) Analysis Service

  MtoZ Biolabs uses 2D DIGE and Western blot technology for HCP analysis.