Proteins, which are widely used for industrial and medical applications, are difficult or impossible to be synthesized chemically. Instead, biotechnological processes are used such as recombinant fermentation. Pichia fermentation is a highly flexible promising method for industrial use. Despite its advances, the production remains expensive, the yields low and the risk of losing a batch is high.
Fermentia is a contract manufacturer of proteins as a final product by recombinant fermentation technology. Within this experiment the specific type of proteins production process, Pichia fermentation, is meant to be optimized. Currently, end-user Fermentia uses manual sample analysis and corrective actions, including reagent addition, based on the results (‘As-Is’ solution). However, time dependent analysis process frequently leads to low product yield or serious product loss. Fermicloud proposes a new way for bioprocess optimization via automatization as well as processing and understanding past process data .
Therefore, this experiment approach suggests a ‘To-Be’ solution which reduces the response time of the control loop and replaces heuristic decision making by a rule library based on big data analysis, which overall leads to higher product yield and better product quality. The solution is based on data driven modelling which requires extension of the parameters space with new variables. Such parameters can be measured by advanced techniques currently not available at Fermentia. Spinsplit LLC, as ISV partner, will provide the necessary IoT ready fluid handling modules which enable to perform the required chemical analysis. Moreover, ISV flagship software product SpinStudio Flow Chemistry will be cloudified in order to provide a machine protocol execution system for the rules obtained by the cloud based on-line process analysis. ESSI.tech will supply Partners with engineering consultancy and production of process specific sensors.
The proteins manufacturing process, based on Pichia pastoris fermentation, currently takes roughly a week and costs typically 30kEUR per 1000 g of protein product. Due to the uncertain process control used currently Fermentia accounts 50% yield and 20% chance of complete losing a fermentation batch causing roughly 3 kEUR loss per batch. As per the expectations of the ‘To-Be’ solution, losing of a batch can be completely avoided, yet the product yield can be increased up to 90%. The aforementioned improvements enable for the end-user to offer more attractive prices to their customers, expecting at least 20% increase in their net annual income taking the current process into consideration. Further cost savings can be achieved by utilizing advanced process data analytics for exploring outlier assets, for improved quality assurance and reduced down-times due to predictive maintenance. All partners may mutually benefit from the CloudiFacturing project through potential growth of net income and widening of client network.