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a) Development & optimization of high-cell-density process for microbial fermentation
● Preparation and test of cell banks
● Optimization of culture medium
● Optimization of feeding strategy
● Optimization of fermentation/cell culture process

b) Development and optimization of high-density mammalian cell culture
● Optimization of base culture medium
● Development of chemically defined medium
● Optimization of feeding strategy
● Development of multiple scale (flasks, bioreactors) processes
● Optimization of key parameters of cell culture process (pH, temperature, dissolved oxygen, carbon dioxide, redox potential ,etc.)

c) Development of high-level expression strains/cell lines
● High-level expression & stable engineering strain (E-coli and yeast)
● High-level expression CHO cell lines, antibody titer higher than 2g/L
● Preparation and testing of cell banks used for GMP productions

d) Development and validation of purification processes
● Development and validation of purification processes (from lab scale to pilot scale)
● Refolding of recombinant proteins
● Deep filtration, Diafiltration/Ultrafiltration process for monoclonal antibodies
● Development and optimization of chromatographic purification steps (affinity, ion exchange, hydrophobic, reversed HPLC and size-exclusion, etc.)
● Technology transfer for processes

e) Formulation development for biologics
● Screening and optimization of both liquid and lyophilized formulations
● Selection of primary packaging materials and Extractables/Leachables testing
● Development of sterile filling process (selection of filling pump, residual VHP in isolator, etc.)
● Lyophilization process development and optimization
● Fill-finish process validation of both liquid and lyophilized formulations