Bioprocessing International (BPI) US West 2021 kicked off its virtual edition this morning, Monday March 29. An annual event, BPI West encompasses presentation, posters and networking events focused on the latest developments in bioprocessing and cell and gene therapy.
A talk this morning, “Integration of Paperless Benchtop Instruments in Clinical Manufacturing,” presented by Simon Barskyi of Genentech, discussed his company’s new SSF Clinical Supply Center (CSC). The CSD will integrate single-use bioprocessing and digital manufacturing for research to clinical applications with the capability for commercial runs.
The facility, which is scheduled to begin operations next year, is designed for cGMP clinical drug substance manufacturing using single-use and closed processing for parallel multi-product operations, as well as cell bank generation. The site includes the ability to quickly reconfigure the space and accommodate future expansions. It features a manufacturing capacity up to 2000 L scale and can conduct as many as 1.5 runs weekly.
Key to the facility will be the absence of paper communication on the manufacturing floor, including recordkeeping. As part of this goal, activities of seven types of analytical instruments (as listed in Group B and Group US Pharmacopeia Chapter 1058 in the Drug Substance Manufacturing Area), including pH and conductivity meters and cell culture analyzers, will be tracked entirely electronically. Among the drawbacks of this instrumentation currently used such settings is that each has its own paper logs, proper calibration cannot be easily monitored for deviation, manual user entry is required, and each type of instrument requires its own automation infrastructure.
Roche selected AGU Industrial IT Solution’s SM@RTLINE DATA COCKPIT (SDC) web-based middleware software to provide real-time control and analysis of instrument data as well as centralized data management via the web. Any relevant results can be passed on batch record evaluation. SDC can also accommodate different analyzer types’ connection requirements. Among the types of software systems SDC can be integrated with are LIMS (Laboratory Information Management Systems), MES (Manufacturing Executive System), ELNs (Electronic Lab Notebook), DCS (Distributed Control System), liquid handlers and OPCs (Open Platform Communications).
The main challenge encountered during the project discussed by Mr. Barskyi was the requirement that three groups–automation IT, the middleware provider, and end-users in process engineering and operations—work together. The biggest benefit he discussed was the ability to centralize data management and automate calibration activities.
BPI West US continues through Wednesday, March 31. For more on the show, click here.