Lonza will develop and manufacture the enzymes at Kourim facility in Czech Republic
Lonza has agreed to manufacture two of AMYRA Biotech’s proprietary enzymes targeting gluten for use in a treatment for coeliac disease.
Under the agreement, Lonza will produce material at its microbial manufacturing facility in Kourim, Czech Republic using its multi-host XS microbial expression technology platform.
After a series of tests, Lonza and AMYRA recently performed an expression feasibility study using the XS technology. Multiple strains, promoters and signal sequences were tested in a high-throughput system to determine the best process for the enzymes and to identify a production strain suitable for commercial product supply. The developed strains achieved high cell-density fermentations and high-titer production of AMYRA’s proprietary enzymes.
The Lonza XS system successfully produced multiple g/L quantities of enzymes of a magnitude greater than previously published. Based on this data, AMYRA will continue to work with Lonza to develop a commercial-scale production process.
We are greatly encouraged by the positive outcome of the expression optimisation and scale-up work
‘The collaboration between AMYRA and Lonza, which began in the early stage of expression system development and is now moving into large scale process development, demonstrates the power of the Lonza XS system,’ said Janet White, Head of Lonza’s Custom Development Services Organisation.
‘Partnering with Lonza from the start enables emerging companies like AMYRA to access world-class expression platforms and development programmes, as well as to secure manufacturing capabilities for the complete product lifecycle.’
Werner Tschollar, CEO and President of AMYRA, added: ‘The scientific know-how and professional integrity of Lonza’s project team enabled us to achieve results beyond our expectations.
‘We are greatly encouraged by the positive outcome of the expression optimisation and scale-up work. Looking ahead, we are excited by the prospective milestones for 2014 and the long-term collaboration with Lonza in view of resolving a very relevant public health issue, gluten intolerance.’