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.