Thematic Analysis Service
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Epitope mapping is a critical technique in immunology and proteomics that identifies the specific regions, or epitopes, on antigens recognized by antibodies. An epitope, also known as an antigenic determinant, is the precise site where an antibody binds to an antigen, triggering an immune response. Epitopes can be broadly classified into two categories: linear (continuous) epitopes, which consist of a sequential amino acid sequence within a protein, and conformational (discontinuous) epitopes...
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• AAV Characterization Service
Comprehensive AAV Characterization is crucial to meet stringent regulatory requirements and ensure the safety, purity, and efficacy of gene therapy products. Regulatory bodies such as the U.S. Food and Drug Administration and the European Medicines Agency (EMA) mandate thorough documentation of vector composition, potency, purity, and stability before approving AAV-based therapeutics.
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• Peptide Drug Analysis Service
Peptides are compounds formed by multiple amino acids linked by peptide bonds and can be prepared via recombinant DNA expression, biological extraction, or chemical synthesis. Peptides represent a unique class of drugs with certain characteristics of small molecule drugs as well as properties of large proteins and other biologics. Most intrinsic signaling molecules are peptide-based, such as enzymes, hormones, and immune response mediators. Over 7,000 natural peptides have been identified.
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• Recombinant Protein Drug Analysis Service
Recombinant protein drugs are produced using recombinant DNA or RNA technologies. This involves the integration of target protein genes into recombinant vectors, which are then introduced into host cells to synthesize specific recombinant proteins. These drugs are primarily designed to replace or supplement proteins that are deficient due to genetic disorders or diseases.
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• Medical Device Analysis Service
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mRNA medication is a novel therapeutic method that utilizes messenger RNA (mRNA). mRNA is a sequence of ribotide that encodes for proteins and can express specific proteins through the translation process within cells. The core principle of mRNA medications is to introduce designed mRNA molecules into the patient's body to produce proteins needed for treatment by utilizing the host cell's translation mechanism, achieving the purpose of treating diseases.
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• Antibody Drug Analysis Service
Antibody therapies leverage human immune system antibodies to treat diseases by targeting specific proteins on pathogens or abnormal cells with exceptional precision. The development of antibody therapies has evolved from early polyclonal sera to monoclonal antibodies, and now to genetically engineered antibodies, focusing on enhancing drug safety, effectiveness, and manufacturing efficiency.
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• Vaccine Quality Research and Testing Solutions
Vaccines are biological products used to prevent infectious diseases. They stimulate the human immune system by mimicking infections caused by pathogens such as viruses or bacteria. Vaccines typically contain weakened or dead forms of the pathogen, parts of the pathogen (such as proteins or polysaccharides), or just the genetic material of the pathogen. These components are sufficient to enable the immune system to recognize them but do not cause the disease.
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• Research on Media Development and Optimization
Research on Media Development and Optimization Culture media are essential mixtures designed to support the growth and metabolism of microorganisms, cells, or tissues. These media provide crucial nutrients and environmental conditions, typically including water, carbon and nitrogen sources, inorganic salts, vitamins, and growth factors. The pH of the media is carefully adjusted to the optimal levels for specific organisms or cells.
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• Generic Peptide Pharmaceuticals Assessment Service
Generic peptide pharmaceuticals are products that replicate existing peptide drugs. These drugs are typically composed of amino acids linked by peptide bonds and are used to treat a variety of diseases, including cancer, diabetes, and immune disorders. Developing these generics requires comprehensive research into synthesis processes, formulation technologies, quality control, and bioequivalence to ensure they match the quality and efficacy of the original drugs.
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