Year: 2013-14

Company: Boehringer Ingelheim

Liaison(s): Rio Denoga, Ken Gomez, Rong Wu

Boehringer Ingelheim (BI), headquartered in Ingelheim, Germany, is a family-owned global corporation founded in 1885 which is focused on Human Pharmaceuticals and Animal Health. The BI site in Fremont, CA is a division of the Global Biopharmaceutical Network. BI Fremont has state-of-the-art process development and manufacturing equipment with the capacity to annually produce over 200,000 liters (L) of cell culture product. BI Fremont currently supports both GMP clinical and commercial production, and has a global track record of over 140 biologic projects including 22 commercial products. Due to the commercial and clinical production capability, capacity, and flexibility of the BI facility, many companies contract with BI as a Contract Manufacturing Organization (CMO). This contract business generates significant revenue to the company. Concomitant to transferring the manufacturing process to BI, these companies must also transfer analytical methods which ensure the product’s efficacy, strength, purity, integrity, quality, and safety. These methods allow on-site/realtime testing for in-process sampling, as well as release and stability testing. Unfortunately, method transfers can be tedious and may take up to 60-90 days to complete. Additionally, because there are approximately 10 method transfers per project, project transfer timelines can take as long as 8-9 months. Lastly, because there may be as many as 3-5 concurrent projects, the organization may be transferring 30-50 methods at a time. The BI Quality Control TMP was tasked with analyzing the current method transfer processes and implementing solutions to streamline the process and reduce method transfer times. The BI TMP team approached this project using the DMAIC (Define, Measure, Analyze, Improve, Control) methodology to construct a current-state process map, identify bottlenecks, eliminate waste in the system, and develop a future-state process map. Additionally, the team interviewed clients to gain input from the customer and conducted industry research to determine how many methods might be waived. This research and analysis enabled the team to create and implement solutions to streamline the method transfer process. In conclusion, the BI TMP Team made recommendations which should enable BI to expedite method transfers. It is hoped that these recommendations might allow Boehringer Ingelheim to reduce the cost and time required for method transfers – and, ultimately allow BI to tackle more projects and generate more revenue.