Problem: Developing of universal pilot system for scaling up of technological process for industrial biotechnology. The system have to be flexible because not all process is finally define, from another side cost of system have to match customer’s budget. The main issue is that process has multi-feeding strategy consequently that requires several feeding vessels with SIP functionality. From another side the main fermentation process are tоok quite long time that much longer then seed time.
Solution: Fermenters volumes were define as 50-500-2000-10000L of total volume. Fed-batch process starts in 2000L and 10000L fermenters. For reducing the price and due to long time of main fermentation process we develop system in that 500L fermenter can be used as feeding vessel for 2000L or for 10000L fermenters after CIP/SIP procedures and preparing of fresh media. The same way we designed 2000L fermenter that after harvesting of the seed material can be used for feeding of 10 000L fermenter. Also we added additional 1500L feeding vessel for 2000L or 10000L fermenters to the system. All fermenters and vessels were equiped with level sensors or DP-level system for control and management of transfer process.
How it works: Piping system for this process was designed to reach maximum flexibility of interconnection between fermenters and feeding vessel. Automation part can manage all processes independently for each fermenter, CIP/SIP/transfer. Using of optical sensor gives customer possibility to manage transfer of seed material in automation mode after cell density reach set-point value.
After calculation of all parameters we have defined that growing of seed materials takes ~ 1 day, main fermentation takes more than 4 days and fed-batch process starts from day 2. Based on this calculation technical team have enough time for CIP procedure + preparing fresh media and make full SIP of vessel. After that sterile feeding solution can be transfered to fermenter according to SOP protocol.
Result: Together with the customer we designed flexible system for process of optimization and got first commercial batches of new products. It gives to the customer an opportunity to test their process for different kinds of fed-batch strategies and gives benefits for their fermentation process. Using this solutions allows us to exclude several SIPable feeding vessels from the order – it gives to the customer possibility to reduce significantly the budget of whole system.