Keynote: Paul McKenzie, Bristol-Myers Squibb

Paul McKenzie, vice president at Bristol-Myers Squibb took us through a breathtaking tour of BMS' standardization of manufacturing using S88 and S95. On the plant floor, BMS uses Rockwell PLCs, through the plant floor DeltaV Batch engine, using OSI PI as the Historian, Maximo as the asset manager, and SAP etc., at the enterprise level. He showed how S88/S95 integrated recipes work in the 'manufacturing orchestration engine' and the 'batch orchestration engine,' so that SFCs with Unit Operations utilizing common vocaulary, and parameters. Recipes have replaced 100 plus page log sheets, documentation errors elimintated. Running by recipe, all electronic execution provides consistency, and compliance oversight on materials and oeprations. BMS uses concurrent operations. There are challenges. People still want to follow the electronics with paper. The quality group releases batches based on electronic recipe review. They are using the reporting tools in near real time rather than waiting six weeks to find a problem. People still have problems integrating data from other sources, and how much data is required for compliance is still a discussion. There is a tremendous power of marrying S88 with modeling tools. Through each stage of development, you can build and improve models to answer critical questions. Feed back knowledge from each campaign batch validates and enhances models, which can either be fundamental or statistical. These modeling tools need to be simple, for all scientists, not just engineers. McKenzie showed a display screen showing "Data Diving the S88 Way" and he showed the importance of process understanding and predicting "at Scale" performance using modeling tools. You don't have to "practice" at the manufacturing facility. You can predict a priori that you are going to be successful at the manufacturing plant. Can we apply S88 thinking to Analytical Space? There are opportunities to reduce overall cycle time. There are ways to express analytical space in the S88 framework. We can get better coordination and information flow between batch and analytical activities. We can leverage drug discovery high thruput workflow approaches for analytical testing. BER- Batch execution recipe BAR- Batch analytical recipe DAN- distributed analytical network PAM- process analytical historian. "So this is the story of Dan and Pam at the bar with a beer." If we can articulate the three parts of the analytical sample plan, we can easily be an S88 recipe: Instrument setup, sample prep, system suitability. McKenzie showed how a structure could be developed, where a parallel system, based on S88/S95, to the process control system, which he calls a "process analytical manager." Recently he'd done a set of simple test of this system, and he believes it will work well. Then he showed a slide showing a potential "real time release" structure. If you re-execute S88 in your plant space AND in your analytical space, you now have visibility into the data that all the millions of dollars in ERP and supply chain modeling can't get you. We need to rethink the balance of funding between ERP and supply chain tools to get the data we need. We need to reinvest in the plant floor information systems, and add the lab to them. Then he took a look at the new E55 standard: Commissioning and Qualification Science, and Risk-Based Approach. There is, using S88/S95, a way to rethink commissioning and process and product validation. If you cncentrate qualification activities on Product Specific Needs and Intended execution model, from pre-commisioning to post commissioning. What should we be doing more? Educate the industry on S88/S95/E55 Shared libraries across API, DP and biologics (both inter and intra company) Better coordination between analytical space and plant floor to reduce cycle time Common interface expectiations for analytical OEM Modeling Challenge Qualification Approaches by capitalizing on S88/E55 Increase the manufacturing experience for many groups (quality, IM, etc.) "We are building a new biologics facility in Devens, Mass." It will be a modular design plant with 6 x 20,000 L bioreactors, making Orencia for rheumatoid arthritis. We will be using the integrated S88/S95/E55 model to operate the plant. We're hiring! --Associate Director for Quality Assurance --Facility and Equipment egnieers -- Manufacturing Systems Engineers

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