Bringing these new products to the commercial market creates a wide range of challenges for leading biopharma manufacturing facilities. Plants operations can often look drastically different once a new commercial manufacturing run is added to production. Our colleague from Sanofi, Jon Forstrom, noted in a recent keynote presentation at the BioProcess International Conference that four in five biopharma plants no longer manufacture the products they were designed for. Instead, they now manufacture other, newer products.
In the second part of our new product development series, we examine ways the manufacturing environment must evolve to accommodate the transition from clinical to commercial manufacturing. We’ll also showcase the way digital twins can provide valuable time and cost saving support to facilities. According to McKinsey analysis, companies who utilize these digital resources to scale up production can see a 25 to 40 percent increase in plant capacity among other improvements in the most critical performance metrics.
Evaluating Supply Chain and Inventory Processes
When it comes time for a site to scale up manufacturing a new biopharma drug, it will be necessary to re-evaluate all elements of the existing supply chain. This could require using an alternate raw material supplier rather than the one used during the clinical phase if they cannot meet the expanded requirements. Depending on the ingredients of the new product, a facility may be able to identify a current supplier able to provide all the necessary materials for existing and new product lines. If a new supplier needs to be sourced, complexities could arise in receiving schedules compounding the initial uncertainty that comes with acquiring a new vendor.
If the vendor list does need to expand and raw materials start to arrive on different timelines, this could also require overhauling the inventory management system to account for the changes. Will supplies for the new drug arrive just as inventory levels for an existing product are at their peak? Does the facility possess the necessary equipment to accommodate the necessary hold times or temperature storage requirements?
With an advanced process modeling tool, planners can easily troubleshoot ways to account for changes in raw material deliveries and unforeseen storage bottlenecks. Planners can adjust the production schedule to relieve inventory pressure or expand the existing storage footprint to accommodate the new influx of materials. The site will also be able to evaluate improvements to their inventory system to handle changing ingredient storage requirements, such as longer hold times or temperature restrictions.
Reallocating Resources for Commercial Production
In addition to acquiring and storing raw materials, it can also be difficult for plants to adapt their processes to optimize the allocation of resources needed for scaling-up new products. Site leaders are often uncertain about how to best adjust labor and equipment schedules to meet the needs of an expanded range of products. If the new product demands a more skilled labor force, human resources may have to invest time to reskill or upskill the existing workforce. Operations leadership might also look to invest in automation to reduce the burden on HR. If the site lacks adequate labor or equipment resources, the plant will need to determine the most optimal production compromise until the shortage can be corrected.
Leveraging a highly accurate, virtual model of a real-world manufacturing plant will provide a greater understanding of main line activities and underlying detailed process dynamics. Because it’s an exact replica of the real site, planners can use the digital twin to test possible changes to best suit the new products. Running experiments with different allocations of labor and equipment can determine the optimal configuration to accommodate the new product. An advanced tool like VirtECS will also identify the most efficient production path to maximize output if critical resources are limited and cannot be addressed immediately.
Adjusting the Production Schedule
Even with all the correct materials and resources in place, facilities often face a lot of uncertainty determining the optimal times to start the various production runs. Planners may try to slate the new product into the various openings presented by the current production schedule. This approach can create unnecessary bottlenecks or challenging changeovers in the overall production schedule. Further, this could decrease run rates, hurt overall plant production output and increase product lead times.
Planners may not immediately recognize the facility is running at suboptimal production because there is a lack of historic data to show what the plant is capable of producing with the new product included. This could force leadership to underestimate how much product can be delivered to market.
Digital twins take the guess work out of production scheduling, even with a new product. Planners will always know the true maximum capacity of their plant’s resources, making it easier to find opportunities to improve the current manufacturing yield and debottleneck production. Consistently identifying and taking advantage of efficiencies in the manufacturing process will lower the overall cost of producing the new drug. Every additional cost-saving effort can often mean the difference between profitability or loss.
VirtECS has been implemented in sites for several global manufacturers to solve their challenges in scaling-up production of new products. In his keynote presentation, Forstrom noted that with the VirtECS digital twin, “We can rapidly simulate scenarios where we fit new products into old plants. Where it would normally take weeks or months to do a full analysis, we’ve turned around some of these analyses with VirtECS in a day or two.” To hear more about Forstrom’s experience using a VirtECS model at Sanofi, you can watch his full presentation here.
