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www.arraybridge.com
Array Bridge Inc. was founded by scientists with extensive experience in drug discovery and biologics development. Array Bridge provides products and services that address two important areas in the development of biologics: biosimilar drug comparability analysis and impurity analysis.
During biosimilar development, biologics comparability is critical to the successful development of the process and product. From cell line selection to process development, from formulation development to change control, comparability is closely related to the molecule¿s safety and efficacy. Array Bridge has developed “antibody arrays” to measure biosimilar drug comparability at the molecular level, providing a sensitive, systematic and robust measurement of biosimilar conformational comparability. This antibody array-based technology can be used at all stages of biosimilar development, from cell line selection and process development to clinical testing and product release.
For impurity analysis, Array Bridge provides ELISA kits and reagents for Host Cell Protein quantitation and Western Blot analysis. All the products are manufactured under cGMP to ensure quality and consistency. In the near future, Array Bridge will also provide Q-PCR-based residual DNA quantitation kits for CHO and E. coli-derived biologics and an ELISA kit for residual Protein A quantitation.
In addition to these products, Array Bridge also provide services to the biotech and life science industries. If you need to analyze your samples for impurities (Host Cell Proteins, residual DNA or Protein A) or for biosimilar conformational comparability, Array Bridge has scientists with experience working under cGMP and ICH guidelines to deliver regulatory-ready results and documentation. Furthermore, we can help you with ELISA method qualification or validation. The company also provides consultation for the development of an effective impurity analysis strategy, enabling your program(s) to meet requirements from regulatory agencies such as FDA and EMA. In addition, we provide enzyme assays for over 850 enzymes, the most extensive enzyme assay collection in one place.
专注领域
Biosimilar 3-D conformational comparability, Host Cell Protein Analysis, Process-related impurity analysis, Antibody-drug conjugate development, Residual DNA analysis, Bioassay method qualification and validation
上海金畔生物科技有限公司
