Array Bridge Inc.

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, Array Bridge provides enzyme assays for over 850 enzymes, the most extensive enzyme assay collection in one place.

Complete List of Products: hyperlink which opens into list of products
Services Offered:
• Host Cell Protein characterization for CHO and E. coli-derived products.
1. One-dimensional gel electrophoresis (SDS-PAGE, Nondenature, Fluorescence stain)
2. Two-dimensional gel electrophoresis (2-D gel, Fluorescence stain)
3. One-dimensional and Two-dimensional Western Blot analysis.
4. Host Cell Protein identification with Mass Spectrometry.
5. Host Cell Protein Risk assessment with Bioinformatics analysis.
6. Impurity analysis program strategy.
•Host Cell Protein ELISA analysis with Certificate of Analysis (CofA) for CHO and E. coli HCPs.
•Monoclonal antibody drug conformational comparability analysis with ELISA (Avastin; Erbitux; Campath; Rituxin; Humira; Synagis; Herceptin; any other monoclonal antibody drug or drug candidates)
•Polyclonal antibody production.
1. Peptide design and synthesis.
2. Peptide and other immunogen conjugation with carrier proteins (KLH or BSA)
3. Antibody production (rabbits)
4. Antibody purification (Protein A or affinity column)
5. Antibody labeling (HRP, Biotin or molecule of interest)
•Customer Host Cell Protein ELISA method development and validation: Develop process (or platform)-specific Host Cell Protein ELISA method and validate the method following the corresponding ICH guidelines.
•Enzyme assays for over 850 enzymes.
•Customer specific biosimilar conformational analysis ELISA development including the design of the antibody coverage, development of ELISA and validation of the method
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