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DEVELOPMENT SERVICES

Analytical Methods Development

Northway Biotech’s analytical methods development team provides high-quality analytical method development services.

We have full analytical capabilities to employ a variety of advanced techniques to elucidate the physical and chemical characteristics of the expressed proteins. Our analytical activities are conducted in-house, allowing us to characterize, monitor and optimize your product’s quality attributes across all stages of development.

Analytical Development Capabilities

  • Assay Development & Validation: Development, qualification, and validation of assays for recombinant proteins, mAbs, pDNA, and viral vectors

  • Liquid Chromatography: SEC, RP, IE, and HIC HPLC method development, qualification, and validation

  • Electrophoresis Techniques: Capillary gel electrophoresis, icIEF, SDS-PAGE, and other protein purity methods

  • Spectroscopic and Binding Analysis: UV-VIS spectroscopy, Solo VPE, ELISA, Octet, and RT-PCR


  • Particle Analysis: Subvisible particle analysis using compendial light obscuration and MFI methods

  • Protein Structure Elucidation: LC-MS/MS for protein structure analysis

  • Cell-Based Biological Assays: Development, qualification, and validation of cell-based assays

  • Extended Characterization: Comprehensive characterization of proteins, pDNA, and viral vectors for product integrity

DEVELOPMENT SERVICES

Cell Line Development

We offer the flexibility of both mammalian and microbial expression systems – and the expertise to develop the optimal cell line for your product.

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DEVELOPMENT SERVICES

Process Development

Our R&D experts work with you to develop processes that can be efficiently transferred and seamlessly scaled up for production.

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DEVELOPMENT SERVICES

Formulation Development

From the earliest stages of development, we are committed to ensuring the long-term safety and efficacy of your product in the finished dosage form.

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