Analytical Development at cGMP Manufacturing Company, Cytovance Biologics
 

Analytical Development Services

Cytovance® Biologics develops, qualifies, and validates product-specific analytical methods to support clients’ production processes as well as research and regulatory requirements. Our laboratories are equipped and staffed to drive the larger project, anticipating requirements and recommending processes for optimum results. Cytovance will transfer in any existing client methods or develop methods de novo, including qualification and validation.

Services and methods include testing for product/process related impurities and developing release and in-process assays in support of mircrobial fermentation, cell culture and purification development employing a variety of methods:

    • BCA /Bradford protein assays
    • A280 protein determination
    • UV-Visible spectral scanning
    • pH
    • Fluorescent activity assays
    • ELISA assays
    • HPLC-affinity, IEX, HIC, SEC, RP-HPLC
    • SDS-PAGE analysis
    • IEF analysis
    • Western blot analysis
    • LAL Endotoxin assays
    • Bioburden determination

Key equipment includes an Agilent 1100 HPLC, Molecular Devices UV/Vis Spectra Max Gemini plate reader, Molecular Devices Fluorescent Spectra Max plus 384 plate reader, electrophoresis cells, semi-dry blotting apparatus, IEF system, KodacGel Logic 440 Imaging System and Millipore Milliflex single head pump for bioburden determination.

In addition, we are pleased to offer and manage other specialized development and validation work through our service partners. Techniques include mass spectrometry, amino acid & carbohydrate analysis, terminal sequencing, and others.

Contact us to discuss your Analytical Development needs or to request a proposal.