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    Research & Development

    POSITION:Home>Research & Development>CRO

    With our rich experience and cutting-edge facilities, Kawin Technology can provide one-stop CRO services for biological product development.

    1) Drug Substances - Fermentation
    Fully automatic fermentation system: 50L-500L
      High density fermentation with E-coli system, 3 expression methods of inclusion body, soluble and secretion
      High density fermentation with yeast system, secretion expression

    2) Drug Substances – Purification
    Based on AKTA protein purification systems
      Multiple scale systems
      Best-in-class chromatographic columns

    3) Drug Product – formulation
    High throughput screening, multiple dosage forms
      Formulation development, including high throughput formulation screening for pre-clinical studies, formulation optimization for early and late stage clinical studies
      Lyophilization development: lyophilization formulation development, lyophilization process development
      Stability studies: force degradation studies, accelerated stability studies, long-term stability studies, freeze-thaw studies, transportation stability studies, agitation stability studies, photostability studies
      Fill-finish process development: UF/DF process, sterile filtration, fill-finish process for vials or pre-filled syringes (PFS)

    4) Analytical methods development
    Cutting-edge analytical techniques
      HPLC methods development: reversed phase, size exclusion, ion exchange, etc, method development and validation
      Bioassay development: cell-based, ELISA or chemiluminescence method development and validation
      Mass spectrometry based methods: method development for peptide mapping, disulfide bond mapping, etc.
     

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