Bioprocess Development & Optimisation
Alpha's R&D and bioprocess development labs are at Babraham Research Campus in Cambridge, England. Here, our scientists 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.
These optimisation skills provide substantial financial returns - one project gave a financial recovery of over £50,000 per batch (£600,000 per year) to the client.
Project examples: these include the production and purification of phage; extended cell line growth studies for mammalian cells; the production & purification of antibodies and Fab fragments; the development of growth parameters for human fibroblasts; supernatant production for 293 cells; cell membrane preparation from recombinant cell lines; growth and productivity evaluations for a serum-free hybridoma; and many others.
cGMP mammalian cell manufacture. For customers requiring cGMP mammalian cell manufacture, the Cambridge team project manage - either in a separate laboratory suite at Cambridge, or in cGMP labs in Penang - mammalian cell bioprocess development, optimisation, scale-up and technology transfer to our FDA / EMEA compliant cGMP manufacturing suites in Penang.
Our team has experience of more than 60 technical transfers, ranging from the transfer of manufacture of monoclonal antibodies between sites around the world, to the transfer and scale up of production of antibody fragments at 12,000 litre scale.
Contact us on +44 (0) 1223 496070 (UK), +60 (0) 4 5048800 (Malaysia) or info@alphabiologics.com for a quotation or further information.
