Problem:Developing a universal pilot-scale system for scaling up the technological process for industrial biotechnology. The system had to be flexible because not all process steps are finally defined, but, from another side, the cost of the system had to match the customer’s budget. The main issue was that process had multi-feeding strategy that requires several feeding vessels with SIP functionality. From another side, the main fermentation process tоok quite a long time (much longer then seed fermenter working time).
Solution: Fermenters volumes were defined as 50-500-2000-10 000L of total volume. Fed-batch process starts in 2000L and 10 000L fermenters. For reducing the price and due to the long time of main fermentation process we developed a system where a 500L fermenter can be used as feeding vessel for 2000L or for 10 000L fermenters (after CIP/SIP procedures and preparing fresh medium). In the same way we designed 2000L fermenter. After harvesting of the seed material it can be used for feeding the 10 000L fermenter. Also we added additional 1500L feeding vessel for 2000L or 10 000L fermenters to the system. All fermenters and vessels were equipped 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/product transfer. Using of optical sensor gives a possibility to manage transfer of seed material in automatic mode after cell the density reaches a set-point value.
SCADA for each fermenter can independently manage CIP/SIP/SOP procedures according to technology steps;
SCADA can in automatic mode transfer seed material from one fermenter to another;
SCADA can in automatic mode transfer feeding media to 2000 and 10 000L fermenter;
For automatic transfer the controller provides CIP/SIP procedure of transfer line in automatic mode according to the material route;
System can automatically transfer materials from 500 and 1500L to 2000L; from 500L, 1500L and 2000L to 10 000L fermenter.
After calculation of all parameters we have defined that seed material growing takes ~1 day, main fermentation takes more than 4 days and fed-batch process starts from day 2. Based on this calculation, the technical team have enough time for the CIP procedure + preparing fresh media and performing a full SIP procedure of vessel. After that sterile feeding solution can be transferred to the fermenter according to the SOP protocol.
Result: Together with the customer we designed a flexible system for process optimization and got first commercial batches of new product. It gives the customer an opportunity to test his process for different kinds of fed-batch strategies and gives benefits for the fermentation process. Using this solution allows lets us exclude several SIPable feeding vessels from the order – it helps the customer to significantly reduce the budget of the whole system.
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