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.