by Kelsey H | May 14, 2024 | Debottlenecking, Process Improvement
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.
by Kelsey H | Apr 16, 2024 | Planning & Scheduling, Process Improvement
The past several years have been a time of accelerated innovation in the biopharmaceutical industry and new drugs are being developed at a rapid rate. According to Deloitte’s 13th Annual Pharmaceutical Innovation Report, the top 20 global pharmaceutical companies spent a combined $139 billion on research & development in 2022.
However, an observation coined “Eroom’s Law” shows a declining efficiency in bringing new drugs to market. The trend, named because it is the inverse of Moore’s Law in microelectronics, shows the cost of developing a new drug has doubled every 9 years. According to a 2016 report published in the Journal of Health Economics, it cost approximately $1 billion to bring 30 new drugs to market in 1950. Today, it costs nearly $3 billion to develop and successfully launch one new drug.
In the following series, we’ll break the life cycle of a new product into two distinct stages: clinical manufacturing and production scale manufacturing. We’ll analyze the critical components of each phase and how a process modeling tool can optimize your facility for success. To begin, let’s look at a new product ready to move from the lab into the manufacturing environment for clinical trials.
Transferring Tech to the Manufacturing Team
One of the most crucial stages in the development of a new drug is the shift from lab-scale to clinical manufacturing. Central to this transition is the tech transfer process. During this phase, all the product information and procedures created by the development team in the lab must be shared with the manufacturing team. This knowledge will be combined with equipment data and production practices to develop a process capable of meeting the supply needs of the upcoming clinical trials.
A significant amount of documentation and knowledge must be organized and transitioned for the transfer to be successful. A process modeling tool or digital twin can be a valuable tool for logging process data and supporting the collaboration between the development and manufacturing teams. A failure at this stage could create a loss of relevant technical knowledge, allowing previously solved problems to reemerge. These setbacks hinder the ability to begin manufacturing the necessary supply of product for clinical trials, delaying one of the most time-consuming parts of a drug’s journey to market.
Unfortunately, industry estimates show these delays are all too common – nearly 85% of all clinical trials experience delays. According to a 2022 report from Statista, the average clinical trial already lasts over 7 years and costs nearly $19 million to complete. Additional delays to the start of a clinical trial program will only compound the problem and jeopardize the journey to recoup the billions invested during development.
Selecting the Optimal Clinical Manufacturing Facility
Once the tech transfer is complete, the manufacturing team should begin a facility fit assessment to ensure the plant can complete the manufacturing process. This might entail evaluating multiple facilities to determine the optimal location. Leadership will look at the availability of all necessary equipment for production and material storage. The site’s current production schedule and overall capacity will also need to be taken into consideration.
Often these assessments can be supported by a digital twin. These virtual models can quickly identify the optimal facility already prepared for the clinical manufacturing needs. If potential gaps or risks present in all facility options, the digital twin can run experiments adding equipment or modifying the plant’s footprint to produce the optimal solution. Since this analysis can be performed in a matter of hours, facility fit evaluations can be completed early in the transition to clinical manufacturing. If these gaps are not discovered until later, they could lead to lengthy design and construction delays.
Mastering Process Design and Qualification
It has been said that clinical trials showcase a new drug’s efficacy, while the clinical manufacturing process determines its ability to succeed in the market. A great deal of scrutiny is placed on the manufacturing process as a new drug seeks approval, and regulators need to be convinced a facility can deliver a consistent product that meets the necessary quality standards. This entails minimizing variations in product batches that could compromise drug quality and risk process failure.
Digital twins become a useful tool during the process design phase because they allow developers an opportunity to test how different components of the manufacturing process will impact product variability and yield. Running these experiments in a digital environment could save an organization a significant amount of time and reduce the amount of costly process qualification runs needed from a test facility. This digital model will lead to a better understanding of the entire manufacturing process and allow for the implementation of stronger control strategies to keep every batch within specifications. A McKinsey analysis in conjunction with the World Economic Forum found that leading biopharma companies who utilized these digital tools saw up to a 50% reduction in deviations, and an 80% reduction in recurring deviations.
Designing for Flexibility
Manufacturing during the clinical stage of product development requires a great deal of flexibility. As data begins to emerge from phase I and phase II trials, formulation issues might be identified, and batches may begin to vary in both composition and size. If a facility is not prepared to adapt to these changes quickly, the entire clinical phase of development could suffer from significant delays and increased costs.
Without access to a digital twin, production decisions are often made that overcompensate for the new demands of the clinical trial and generate excessive waste. This excessive waste could reduce the budget available to expand the trials to new sites, slowing the progression toward drug approval. It could also place increased demands on the equipment within the facility and create cascade disruptions for other products in the plant’s portfolio.
Preparing For Scale-Up
While addressing the demands of clinical development, it is essential keep commercialization in mind. Much of the process design stage requires focus on data collection and regulatory compliance, leaving little room for long-term process optimization. Many facilities will focus on getting clinical studies underway quickly and delay consideration for scale-up needs until late into Phase II trials. They might arrive at a validated manufacturing process which meets the needs of the clinical stage, but it is often overly complex and lacks efficiency.
Faced with an urgent need to scale-up, facilities will often resort to simply stretching the small-scale clinical manufacturing operation to the new commercial scale demands. Many of the components in the process quickly become inefficient with this approach to expansion and increased quality-control issues risk the integrity of your new product. Making changes to the existing manufacturing process can be extremely costly, especially if a comparability bridging study is required to approve the new process.
Developers should utilize a digital twin during the process design phase to plan for long-term commercialization. Allocating time to this planning effort might slow down the early stages of process development, but it could avoid costly inefficiencies and time-consuming setbacks when demands of scale-up production arise later. A virtual model can quickly identify risks for product deviations or production bottlenecks when the existing processes are scaled up. Planners can troubleshoot solutions and identify any necessary capital investments early before they can lead to production delays. Despite the initial investment of time, this step ultimately speeds up a new product’s time to market.
Maximizing Revenue Potential
Digital twins are a critical tool for navigating new products through the clinical development phase towards registration. They also can have significant implications for company revenue. It has been estimated that leading pharma companies can lose up to 80% of revenue when a patent expires. EY reports over the next 5 years, an astounding $356 billion in worldwide sales are at risk from patent expiration. Utilizing powerful modeling tools like VirtECS to identify avoidable setbacks in the early stages of product and process development can add up to millions, or billions, of dollars in additional revenue when the clock is ticking.
If you’re interested in learning more about how VirtECS can improve your new product development process, download our short overview guide and check back for part two of this series next month.
by Kelsey H | Mar 4, 2024 | Planning & Scheduling, Process Improvement
In many real-world manufacturing environments, disruptions occur frequently, forcing unexpected adjustments to their production schedules. Some of these disruptions, such as supply chain delays or equipment breakdowns, are simply inevitable, even for the most proactive and prepared organizations.
Naturally, changes to the production schedule will affect the timeline of when the output can be completed. However, there are also other unexpected ripple effects of schedule changes that can impact the site’s broader operations. Understanding the full impact of scheduling adjustments can help your team better proactively prepare for these situations, as well as look for solutions that will minimize the ramifications of each change.
Inventory Management
One common consequence of production schedule changes is that raw material inventory will be higher or lower than previously projected. For example, if a start time is delayed by two hours, the raw product will need to be stored for two hours longer than planned. This can cause issues if your plant is tight on inventory space. You may unexpectedly lack space for incoming deliveries. On the other hand, if a different project is moved up in the schedule to replace the delayed run, sites following a just-in-time inventory philosophy may not have the necessary materials available yet.
Managing inventory during production schedule changes can be especially challenging for industries like biopharmaceutical manufacturing, which may have raw materials with strict storage requirements. If product is stored for too long (or not long enough) at suboptimal temperatures, it may result in wasted resources, which increases costs and causes further disruptions. To avoid these problems, it’s critical to consider inventory requirements when adjusting the production schedule.
Capacity Utilization
If constant schedule changes are leaving your plant continuously behind on production, it can become very difficult to accurately track your site’s data. When schedule decisions are made on the fly and operations are in flux on a day-to-day basis, your team may not be able to accurately measure the site’s true capacity limits.
Accurate data on site capacity utilization is crucial if your organization has goals to increase profitability or introduce new products to the plant. If the site can’t determine whether it has any capacity available, it hinders its ability to make smart decisions about new projects or scale up production on a product with surging demand. It can also be difficult to properly forecast and plan around future demand. As a result, the company is forced to miss out on maximizing output and landing potential sales they could have earned with a smarter scheduling solution.
Overtime
Depending on how long production is delayed during a schedule change, your site may need to utilize overtime labor in order to meet deadlines. While some use of overtime is unavoidable in manufacturing, it also leads to increased labor costs, especially if labor schedules aren’t optimized to distribute employees’ hours equitably.
In addition to facing higher costs, plants that regularly use overtime production tend to be less productive per hour. According to a manufacturing report from the International Labour Office, a 10% increase in overtime can result in a 2.4% decrease in output per hour. Making a concerted effort to keep production during regularly scheduled hours can help keep costs down and efficiency up throughout the plant. An employee engagement survey from Kronos Incorporated indicates that employee burnout from too much overtime work is responsible for up to 50% of businesses’ annual turnover.
Supply Chain
If your site can’t efficiently adapt to schedule disruptions and wants to avoid utilizing overtime, it may ultimately lead to backorders and out-of-stock products. When production runs behind, it often results in missed deadlines throughout the rest of the supply chain, such as scheduled product shipments with logistics partners. Failing to fulfill these demands is not only a frustration to vendors and customers; it’s also missed revenue for the company, both immediately and potentially long-term if consumers find suitable alternatives.
Maintenance
It is not uncommon for plants to utilize time allocated for preventative maintenance or special projects to offset the impact of production delays. While these compromises might help the facility meet the proposed deadline, they could come at a significant long-term cost and create future disruptions. Overlooking necessary maintenance increases the odds of equipment failure requiring a lengthy repair or unnecessary capital expenditures on a replacement. Delaying special process improvement projects limit the plant’s ability to realize its capacity potential. At minimum, these maintenance or improvement tasks will need to be squeezed into sub-optimal timeframes that will impact normal operation.
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Without an advanced planning and scheduling tool, plants are left reacting to changing site conditions with last-minute, unoptimized schedule changes that can result in these troubling issues felt across the site. VirtECS is a unique planning and scheduling solution that solves many of these challenges for clients in a range of industries. VirtECS will not only suggest the best schedule based on your plant’s individual constraints, but it can also handle sudden schedule changes and account for subsequent adjustments that will need to be made throughout the production process.
As a finite scheduler at one of our biopharmaceutical clients put it, “VirtECS handles all of the ripple effects to the schedule when things change. It is a big time savings in a complicated process with lots of constraints.” If you’re interested in learning more about how VirtECS can improve your planning and scheduling processes, download our short overview guide to find out about the many benefits of implementing the tool at your plant.
by admin | Nov 20, 2023 | Planning & Scheduling, Process Improvement
This presentation will discuss a unique and practical learning framework – VirtECS (Virtually Exhaustive Combinatorial System) – to rapidly (1) enable a high-fidelity model of bioprocessing and (2) search the many possible process schedules to find a high-performance way to operate. VirtECS improves capital efficiency, drives throughput increases, and promotes cost reduction. VirtECS can be used to establish manufacturing social media that promotes continuous improvement, complexity mitigation, and teamwork.
by Kelsey H | Nov 14, 2023 | Industry News, Process Improvement
The past several years have brought frequent and abrupt changes in consumer demand. The COVID-19 pandemic brought sudden surges in spending on household necessities and cleaning products, while the subsequent recovery has resulted in pent-up demand for leisure products and services, among other industries.
In these scenarios, when consumer demand for product suddenly increases, their manufacturing plants may have the opportunity to book new, profitable projects. However, all too often, sites can’t determine if they have the necessary capacity available to take on the increase in production. As a result, the plant can’t commit to the project and ultimately misses out on added revenue.
This is a common scenario for many companies today. According to the G.17 Industrial Production and Capacity Utilization report, the US manufacturing industry is averaging just 79.67% capacity utilization in 2023, down more than one percent over last year. The unused capacity represents millions or even billions of dollars in untapped sales for the industry.
Of course, addressing capacity utilization is an incredibly complex issue. Without a tailored and intelligent solution, identifying sites’ true capacity and optimizing utilization is nearly impossible. On the other hand, plants that invest in a digital twin and planning & scheduling tool can quickly identify opportunities to optimize their processes and fit in added capacity without disrupting current demands.
How VirtECS Plant Models Optimize Utilization
Virtual plant models, such as VirtECS, are designed to simulate each site’s unique design and processes to address bottlenecks that limit their capacity. In the process of analyzing the plant layout, VirtECS can determine the exact amount of excess capacity available. When plants are met with surge opportunities, this knowledge is invaluable, and can be the difference between accepting a new project or turning down a potential new source of revenue.
VirtECS can also take capacity utilization a step further with its extensive scenario analysis capabilities. Using its virtual model, VirtECS can rapidly explore the most attractive production scenarios and select the best possible option, even accounting for which product demands are given higher priority. With this analysis, sites can quickly evaluate which production plan results in the fewest bottlenecks and highest total output. Sites can then add in the potential new project and re-run the analysis to determine if the time, effort, and resources it would need to complete production is worthwhile.
Addressing Future Opportunities with Sales & Operations Planning
To prepare in advance for future changes in consumer demand, we’ve seen several clients have success using VirtECS as a sales & operations (S&OP) planning tool. By adding in finite capacity planning on top of the detailed plant model, VirtECS can update its analysis based on market forecasts, as well as your site’s own historical data. Clients that utilized this feature have been able to use their available capacity to make smarter production decisions and maximize output in anticipation of increased market demands.
Once the production schedule is set, sites can also use VirtECS to address the subsequent adjustments the plant will need to make to account for any added capacity. For example, sites can connect VirtECS to their inventory system to improve supply planning, giving the plant insight on the optimal amount of raw material it should keep on hand to meet the coming production needs. In addition, VirtECS can analyze the site’s labor allotment within its virtual model to address whether more employees will need to be added to the shift, or if the distribution of labor can be optimized to cover the additional projects. To learn more about how to use VirtECS for S&OP, check out our recent articles on demand planning and supply planning.
by Kelsey H | Sep 14, 2023 | Process Improvement
When Facebook, LinkedIn, and other social media sites hit the Internet in the 2000s, they completely changed the way people communicated with each other online. In addition, they gave businesses an avenue to gain insights from their audience and provide important news updates instantly.
Creating accessible communication channels has long been a challenge for manufacturing plants. In a busy and complex manufacturing environment, employees are often unable to receive real-time updates through traditional methods like email or word-of-mouth. When a new shift comes in, schedule changes and other important adjustments can get lost in the shuffle.
That’s where a tool like VirtECS Symphony comes in. It’s become known in the industry as “manufacturing social media,” because while sites like Facebook facilitate conversations among the general public, VirtECS Symphony helps plants improve communicate between departments to streamline production across the site. By utilizing this kind of tool, manufacturers can benefit from several key features and facilitate smart manufacturing to improve their site’s operations.
Speed Up the Exchange of Information
One of the first benefits manufacturers often notice immediately with VirtECS Symphony is a faster and smoother exchange of current information to support plants’ smart manufacturing efforts. VirtECS Symphony will publish the current production schedule to employees’ devices and screens across the plant, while also allowing for comments and messages between users. With the VirtECS Symphony platform, everyone on site can stay up to date on schedule changes as soon as they’re published, which results in more accurate production runs. Schedule updates are reflected on VirtECS Symphony in near real-time, and new comments are refreshed automatically to ensure no messages will be missed. In fact, we’ve even heard one of our clients refer to the tool as a “running production meeting,” thanks to its ability to continuously communicate many of the topics typically covered in those meetings.
Improve Coordination Between Groups
Using manufacturing social media, plants can also facilitate communication between groups or departments that may not normally interact. When a user makes a comment on the schedule, any employee located throughout the plant can see the message instantly and adjust as needed. Without a communication platform like VirtECS Symphony, it could take much longer to deliver the updates to every department. Comments and messages can also be viewed across shifts, so the next employees coming in can immediately begin working with the most current information without having to comb through emails or written notes. With increased coordination among every group in the plant, your organization can avoid costly delays and wasted product batches.
Increase Accuracy & Efficiency
Given that your site will have more people who can view and comment on your production schedule, there will also be more opportunities for those people to catch errors or potential improvements. Without manufacturing social media, the production schedule may only be reviewed by the planning and scheduling team. However, if you use VirtECS Symphony to publish the schedule, it will get reviewed by employees from every corner of the plant. Helping more people get eyes on the schedule will make it more likely for someone to catch errors, should a problem arise. Providing a platform to get input from other departments also presents an opportunity for different groups to notice opportunities to lower costs or increase run rate that may not have been identified otherwise.
Provide Transparency and Impact to Employees
Manufacturing social media also provides other benefits in addition to operational efficiency and accuracy. Using VirtECS Symphony and other tools to improve communication can also impact employees’ overall job satisfaction. Giving everyone at the plant access to the production schedule and providing them with an opportunity to share input helps each employee feel like a valuable member of the team. According to a Qualtrics report, employees who are highly engaged in their work are 87% more likely to stay with their current company. If your organization wants to limit turnover and keep employees who produce quality work, it’s essential to help them feel involved.
If you’re interested in learning more about what a manufacturing social media tool like VirtECS Symphony can do to benefit your plant, download our short guide for more details.
