July / August 2023

CoP Leader Profiles: Christian Wölbeling

Marcy Sanford
CoP Leader Profiles: Christian Wölbeling

Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™ Community of Practice (CoP) Steering Committee, Christian has also been very involved with the GAMP® and Process Analytical Technology CoPs, as well as the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate.

He has been on planning committees for ISPE conferences, on author teams for the ISPE GAMP® Guide: Records and Data Integrity and the ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition), and co-led the ISPE APQ Guide: Process Performance and Product Quality Monitoring System author team. He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™. Christian has been with Körber for more than 30 years and is currently Executive Industry Advisor and Senior Strategic Account Manager, based in Lüne-burg, Germany.

A digital pioneer for the pharmaceutical industry, Christian began working at Werum Software & Systems (now Körber) in 1992. “Back then, we were a very small company of 65 people. Two of our main clients were makers of airbags and cigarettes — very different products, but similar in that you must be very precise when manufacturing both. We developed recipe management and manufacturing software which controlled and documented these processes.”

“After the reunification of Germany, many pharmaceutical companies were being built. At Werum, we started developing software for Jenapharm, which is now a part of Bayer, and a generics company in Slovenia. These initiatives grew to projects with Novartis, Organon, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bayer, Amgen, Merck, J&J, and many other top pharma manufacturers.”

Now Körber is an international technology group with about 12,000 employees and more than 100 locations worldwide. The Körber Business Area Pharma offers a unique portfolio of integrated solutions along the entire pharmaceutical value chain.

An expert in automation and process optimization, Christian and fellow ISPE member Marcel Staudt originated the concept of Pharma 4.0™ in 2015 as a “plug and produce” concept to bridge the automation concepts found in Industry 4.0 with the pharma-specific ICH guidelines. Open to all ISPE members, the Pharma 4.0™ CoP’s objective is to help pharmaceutical organizations leverage the full potential of digitalization to provide faster therapeutic innovations and improved production processes for the benefit of patients. Subcommittees within the CoP are working on holistic digital solutions, process maps, critical thinking, Validation 4.0, machine learning and automation, continuous process verification, and process automation.

Christian believes, “If we break the silos between quality, operations, and engineering, and allow them to work together, we can make this da-ta-driven holistic control strategy happen. Also, we have to digitalize the Pharma Quality System as of ICH Q10. This is what the Pharma 4.0™ operating model is, one of its focus areas. It is bringing the regulatory piece together with the digitalized operations and best-practice engineering pieces.”