Biopharmaceutical Impurities Analysis Service

Testing, identifying, quantifying, and controlling pharmaceutical impurities are crucial for ensuring the purity, safety, and quality of both drug substances and finished drug products. Pharmaceutical impurities originate from a variety too. This includes starting materials and their contaminants, reagents, catalysts, solvents, intermediates, excipients, leachables, and degradation products. These contaminants may be organic, related either to the process or the drug, or they could be inorganic or elemental impurities. 

 

Since these impurities are often present at very low or trace levels in complex sample matrices, highly sensitive and specific analytical techniques must be used.These methods are essential not only for determining impurity levels but also for gathering the necessary data to conduct relevant risk assessments or to fulfill regulatory submission requirements. A prominent concern in this area includes nitrosamine-related impurities, such as N-Nitrosodimethylamine (NDMA), which have been identified by the US FDA as significant due to their potential formation during the manufacturing process.

 

MtoZ Biolabs offers pharmaceutical impurity analysis for both new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)), supporting product development from initial stages through to the entire lifecycle of the drug product.Our services include professional analysis for extractables and leachables, testing for elemental impurities, analysis of residual solvents (OVI or VOC), and identification of process-related impurities.Furthermore, we specialize in the highly sensitive and specific development and validation of methods aimed at detecting and controlling genotoxic impurities, such as nitrosamines. For biologic therapeutics, we deliver comprehensive services to determine bioprocess residuals and biopharmaceutical product-related impurities.

• • 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

  -

• • 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.

• • Native Mass Spectrometry Analysis Service

  Native mass spectrometry (Native MS) facilitates direct determination of a protein's molecular weight. It facilitates the study of intact proteins, non-covalent protein-protein interactions, and protein-ligand complexes within biological systems, addressing the limitations of traditional mass spectrometry technologies in the precise quantification of complex drug molecules.

• • SDS-PAGE Based Protein Purity Analysis Service

  MtoZ Biolabs has developed and optimized a SDS-PAGE based workflow, and provides an accurate analytical service for protein/peptide purification study.