Genentech Expands California Plant Erecords Capabilities

Biologics manufacturer Genentech will utilize tools from Honeywell to supply an integrated manufacturing control system, Honeywell said May 16. The control system is designed to produce consistency in production variability and a single erecord of operations. The system will be used at Genentech’s Vacaville, Calif. plant, which is currently undergoing a major expansion.

Genentech researchers develop medicines used to treat cancer, cystic fibrosis, heart attacks and asthma, among other serious and life-threatening diseases. The new system, which will integrate Honeywell’s Experion process knowledge system (PKS) and its POMSnet manufacturing execution system (MES), will support the plant’s operational efficiency, provide erecords of each batch of drugs produced and help reduce operator errors. Honeywell is expected to deliver the system in the next few months.

In addition to Experion PKS and POMSnet, Honeywell’s solution features total plant batch and uniformance process history. The applications will enable Genentech to collect, store and analyze data more efficiently.

The integrated system will help reduce data-entry errors made by plant employees through “point-of-use” verification, Honeywell said. This means the system not only verifies that equipment and materials used in processes are correct, but also checks their quality and availability.

Experion PKS, which is used at some of the world’s largest biotech manufacturing facilities, is a scaleable system that complies with 21 CFR Part 11, Honeywell said in a May 16 statement.

POMSnet MES, which Genentech plans to implement at other plants in addition to the Vacaville facility, is a web-based tool designed specifically for pharmaceutical and biologics manufacturing that manages product specifications. POMSnet also complies with 21 CFR Part 11, as well as ISA S-88 and S-95 manufacturing standards.