Thematic Analysis Service

• • 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.  

• • Medical Device Analysis Service

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• • mRNA Drug Analysis Service

  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.

• • 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.

• • 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.

• • 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.

• • 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.

• • Biosimilar Assessment Service

  Biosimilars are biological products that are highly similar to an approved original biological drug (reference or brand drug) without any clinically meaningful differences in quality, safety, or efficacy compared to those approved. Biosimilars typically enter the market after the patent protection period of the original drug has expired, providing a more cost-effective treatment option.

• • PROTAC Drug Off-Target Protein Assessment Service

  Proteolysis targeting chimera (PROTAC) drugs offer a novel approach to disease treatment by leveraging the body's innate protein degradation pathways. In contrast to traditional small-molecule inhibitors, PROTAC drugs promote the degradation of specific proteins rather than directly inhibiting their function, thus mitigating or eliminating their role in disease progression.  

• • Biopharmaceutical Stability Analysis Service

  Biopharmaceutical stability analysis is crucial for assessing the safety, efficacy, and quality of biopharmaceuticals throughout their storage, transportation, and usage. This analysis evaluates changes in the chemical, physical, microbiological, and biological properties of the drugs.