A subsidiary of Swiss company Ferring Pharmaceuticals says they’re among the first to implement electronic batch records (eBR) throughout a biotech manufacturing process. Bio-Technology General (BTG) in Israel reports that they began to eliminate paper records on their packaging lines in 2020. They now say most of their recombinant protein production lines use eBR.

“The next challenge is going deeper into automation, not just going into the batch record, but having the eBR talking to the software for, for example, protein purification,” explains Reut Kornasio, PhD, manufacturing execution system (MES)/eBR and recovery and purification group manager at BTG.

Kornasio explains that eBR works like a car GPS. It doesn’t drive the car but does guide the production process. About three hundred calculations are involved in the production of a single batch of protein, she says, and if the wrong parameters are input to the system, or are out of specification, the eBR will raise an alert.

Implementing in the biomanufacturing process

According to Kornasio, implementing eBR in a biotech manufacturing process was difficult because the paper batch record ran to a several hundred pages, and every calculation and equation had to be translated into digital format. The eBR, for example, contains an electronic logbook that checks whether a vessel is clean and well maintained, and provides an alert if it’s not suitable for use.

“There were so many things happening in parallel that it was a huge challenge,” notes Kornasio. “But after we learned to do that for one [production] line, it was easy to do it [again] with the next.”

Implementing the eBR provided immediate benefits, points out Kornasio. “When you have such a huge batch record, it takes several days for people in QA [quality assurance] to review,” she explains.

The eBR only needs to be checked if any exceptions have been flagged during the production process, saving time and effort. “It’s a huge time saver,” she continues. “We felt the benefit on the first day we went live.”

Other benefits include a reduction in human error, as operators don’t need to make manual calculations. Also, Standard Operating Procedures (SOP) for the production processes are held automatically in the eBR. More benefits include trackability, tight process control, time monitoring, and process verification, she says.

Kornasio says BTG intends to continue making improvements to eBR, as well as connecting more devices. She attributes the success of the eBR deployment to engaging production staff in the implementation process. This includes having a power user in each team, who can act as an ambassador for the eBR.

“It’s about taking the teams with you,” she tells GEN. “Right from the start.”

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