Bioprocess Development & Optimisation

Alpha's R&D and bioprocess development labs investigate, develop and optimise biomanufacturing processes for bacterial, yeast, baculovirus, insect cell or mammalian cell cultures. R&D and bioprocess development services usually involve working at up to 10-litre capacity in bioreactor, shake culture, roller bottle or wave reactor systems.

Typical R&D and bioprocess development services can include:

  • Small-scale production for quality assessment
  • Expression plasmid expression / purification
  • Mammalian cell transfection and clonal selection
  • Cell line suspension and serum-free adaptation
  • Cell line cloning and high expression selection
  • Cell banking for "pre-master" cell bank candidate clones
  • Upstream (cell culture) process investigation, development & optimisation
  • Downstream (protein purification) process development
  • Assay development for specific proteins or products
  • Development and Technical Reports
  • Definition of process operating parameters and "edges of failure"

Amongst other things, our bioprocess development team have deep experience of

  • Developing the optimal parameters for a wide range of chromatography systems
  • Identifying media formulations that maximise the expression of product from cell lines
  • Deriving Tangential Flow Filtration (TFF) processes that give the best yield of product
  • Optimising ammonium sulphate precipitation conditions to maximise product recovery
  • Developing novel ELISAs for the quantification of antigens and antibodies.

cGMP mammalian cell manufacture. For customers requiring cGMP mammalian cell manufacture, the team project manage - either in a separate GLP or cGMP compliant laboratory suite - mammalian cell bioprocess development, optimisation, scale-up and technology transfer to our FDA / EMEA compliant cGMP manufacturing suites in Penang.

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