Why Biotech Facilities Fall Short of Targeted Capacity

Why Biotech Facilities Fall Short of Targeted Capacity

Those who work in the biotechnology industry already know that capital projects at manufacturing facilities tend to fall short of their targeted capacity levels. According to McKinsey, pharmaceutical manufacturers utilize less than 35% of existing capacity, compared to 85% capacity utilization for consumer products manufacturers. If plants could boost utilization to 60%, only one third of existing facilities would be needed to produce the same output.

It begs the questions: why are so many plants still missing out on potential revenue or cost savings? In many cases, organizations aren’t even aware they have been minimizing their own throughput, or they assume there isn’t any way to avoid it. Below, we discuss some of the areas we’ve seen plants struggle with and discuss possible solutions to increase capacity utilization for biotechnology facilities.

Back-of-the-Napkin Assessments

Despite the many exciting innovations that come from the pharmaceutical and biotechnology industries, these companies still traditionally take an informal approach to capacity calculations. In fact, some of the largest plants in the world still base capacity usage on vague estimates and group consensus, rather than precise data. Others consider the capacity of similar plants and assume their facility is performing exactly the same, without accounting for any differences in design.

When you think about how complex and advanced most biotechnology facilities are today, you can see why it’s a problem to rely on approximations – especially when each batch of product results in thousands or even millions in revenue. Facilities that don’t use a more deliberate, data-based approach will unknowingly overlook potential performance constraints, and as a result, fail to achieve targeted capacity levels.

Underestimating Existing Opportunities

Similarly, some plants underestimate their true total capacity, and make utilization calculations based only on existing conditions. For example, a facility that is running two full shifts per day during the work week may think they have used 100% of their capacity, because they’re producing as much output as they always have. Realistically, though, they may have an opportunity to add a third shift or expand production during the weekend.

Underestimating current plant utilization often has costly consequences. Manufacturers who haven’t calculated the true maximum capacity of their current facility may choose to expand the space or build a new plant in order to increase output, which can cost many millions of dollars. On the other hand, tapping into unused capacity only requires additional labor and materials – which a new facility would also require anyway.

Inefficient Production Methods

While miscalculations play a major role in capacity utilization issues, part of the problem has historically been out of pharmaceutical plants’ control. For years, batch manufacturing has been the definitive production method for biotech and pharmaceutical facilities, and it’s still the most common approach used today. Batch manufacturing requires a multi-step production process with lengthy hold times and equipment setup in between. Naturally, this process tends to be less efficient than other production methods adopted by different industries.

However, this obstacle may be changing soon, as more pharmaceutical plants shift to a continuous production model as recommended by the FDA. Continuous manufacturing minimizes hold times, which allows operators to produce more output in the same amount of time. Thus, plants are able to increase efficiency and increased their total capacity usage.

As for the other capacity issues plants face, capacity analysis software is a key tool to begin performing more precise calculations and identifying constraints. An advanced capacity planning tool, such as VirtECS®, uses your plant’s unique specs to evaluate bottlenecks and pinpoint opportunities for increased throughput. Additionally, manufacturers can use the capacity analysis tool to measure the impact of potential capacity investments in the future. For more information on how VirtECS® increased capacity utilization for a major pharmaceutical client, please see our article published by Biopharm International. https://www.pharmtech.com/view/using-simulation-address-capacity-limitations-0

 

Increasing Efficiency for Small Batch Pharmaceutical Manufacturing

Increasing Efficiency for Small Batch Pharmaceutical Manufacturing

In recent years, leading biopharmaceutical manufacturers have started testing the use of small batches to produce highly custom pharmaceuticals developed from research on genetic variations. It’s an important advancement in the medical field, as customized products can help healthcare professionals provide more targeted and personalized care to their patients. As such, it’s become a high-priority area for pharmaceutical companies, and according to the FDA, more than 40 new products utilizing gene therapies may be approved by the end of 2022.

However, customized products are often much more complicated to produce than standard mass market pharmaceuticals. Production can become more time-consuming, and products must be tested and tracked rigorously. When batches have even slight differences, any issue with quality control can have disastrous consequences. Plus, it may be difficult or even impossible to track long-term market demand for high-precision products.

To improve their operational efficiency, there are a few areas small batch manufacturers should focus on. With these strategies, plants can help create the valuable, customized products our healthcare system needs without impeding their internal processes.

Gather Extensive Data

When looking for ways to improve efficiency, the best tool manufacturers can give themselves is data. For biologics manufacturers working with small batch precision medicine, advanced technology is a necessity to gather ample production data and gain a complete understanding of their operational capabilities. This data can help point to inefficiencies, bottlenecks, and opportunities within the plant.

To gather a more comprehensive set of data, plants will need to begin integrating a variety of tools and software. Devices such as smart sensors can be added to existing equipment to provide real-time insights on their performance. Even if your organization can’t invest in sensors for the entire plant upfront, gradually implementing them over time will still provide helpful additional data.

Some manufacturers have also utilized blockchains to track products through their life cycle and ensure each batch is safe from contamination or other damage. In addition to providing added security, using blockchain can also provide companies with valuable data throughout their entire supply chain. However, only about one in four pharmaceutical manufacturers have implemented blockchain technology, according to research from the Association for Packaging and Processing Technologies.

Implement Flexible Tools

In the process of gathering data, many manufacturers discover they have the capacity to produce more small batches of custom pharmaceuticals, but their current processes and schedules aren’t properly aligned to achieve their goals. Organizations in this situation can significantly benefit from processes that support increased flexibility during production. When manufacturing schedules can be quickly adjusted as needed, it gives plants the ability to respond to changes in demand in real time.

To give themselves more flexibility, some pharmaceutical plants have shifted away from batch manufacturing and instead use continuous production to reduce hold times that can cause longer delays. In recent years, continuous production has emerged as an optimal strategy to fit the needs of small batch precision pharmaceutical manufacturing. The FDA and other experts have also recommended pharma plants switch to continuous production models.

VirtECS®, our advanced planning and scheduling tool, is an ideal tool to analyze how plants can implement their own continuous production plan. VirtECS® is backed by decades of research and has helped numerous pharmaceutical manufacturers optimize their facilities across the world. Additionally, in the process of creating optimized schedules, VirtECS® also captures valuable data that can be used to further improve internal processes. To find out more about continuous manufacturing and the role we can play in optimizing production, check out our other articles here.

The Value of Collaborative Tools in Manufacturing

The Value of Collaborative Tools in Manufacturing

For many manufacturing plants, the constant miscommunication between systems and departments is a scenario that is all too familiar. With so many moving parts within the facility, it’s inevitable that someone will miss an update and be misaligned on the latest plans.

To ensure a smooth and accurate production process, it’s critical for all systems within a complex manufacturing plant to work together. In the most efficient cases, each program routinely and automatically shares information with other key tools in the facility.

This kind of high-level collaboration can save your team valuable time and keep all data current across the organization. There are many specific benefits to using a shared system of programs, but perhaps most importantly, digital collaboration can boost overall productivity at manufacturing plants by up to 30%, according to research from McKinsey.

Data Sharing Leads to Faster Problem Identification

For decades, manufacturing has been changing and becoming increasingly technology focused. As a result, plants are incorporating many kinds of advanced software into their daily operations, and these tools are gathering more data than ever. Many facilities today use various software for every aspect of manufacturing, from inventory management to resource planning. When used over time, these tools can offer a wealth of information about the current state of the plant. The data collected can help employees identify inefficiencies and weak spots much earlier, as long as the information is harnessed effectively.

Unfortunately, raw data isn’t always insightful when presented on its own. For example, from one set of data, you may learn that a machine in your process experienced lower throughput. If you can’t connect those statistics to the total production time or the amount of labor on hand that day, the information lacks important context. However, if you can access all the available tools and review multiple data points simultaneously, it can give your team a full picture of the plant’s current strengths and weaknesses.

Collaboration Encourages Smart Decision-Making

Once you have a better idea of the pain points your plant is experiencing, your team can use those insights to make better, more informed decisions across the organization. Before seeing the full, data-integrated picture, your leadership may have incorrectly assumed which investment would benefit the plant most – say, a new production line. In reality, the collaborative data may reveal that updating current machinery or hiring more employees would provide a bigger boost in productivity and increase revenue. Without that valuable information, the business would not have invested optimally or received the highest return possible.

How to Create a Collaborative Framework

Though there are many benefits to sharing information across each tool in the plant, it’s not always a simple process. Many plants have already ingrained themselves within existing systems that may not support collaboration. As a first step, we recommend implementing a scheduling tool that syncs with all existing systems and gathers information on internal processes. It’s especially helpful if the tool facilitates real-time communication with employees, so everyone in the plant can quickly access any changes to plant operations. From there, your organization can ensure any other new software acquired over time will work with your existing data hub to create a fully integrated system of information.

Our advanced planning and scheduling tool, VirtECS®, can integrate with many other manufacturing programs to provide a data-rich, seamless experience for our users. While spreadsheet-based models of scheduling often become cumbersome and accessible only to their creators, VirtECS® can be shared and used across entire organizations. Our web-based module, VirtECS® Symphony, helps distribute the finished and optimized schedule throughout the plant in real time to keep all employees up to date. For more information on VirtECS® and VirtECS® Symphony, explore our overview guide. 

Benefits of Proactive Planning in Manufacturing

Benefits of Proactive Planning in Manufacturing

In business, we hear all the time about the importance of being “proactive, not reactive.” In reference to manufacturing, it can be more complex to unpack the true meaning of being proactive. When you’re busy running production lines day in and day out, how can your plant realistically find time to be proactive?

Whether you’re aiming to become an innovative force in your industry or simply establish an advantage over competitors, it’s essential to spend time analyzing everything that could possibly go wrong during production. Organizations that only address problems as they arrive are unfortunately always one step behind each trend and opportunity.

That’s where being proactive comes in. If your plant develops feasible step-by-step solutions to each problem before it occurs, you can avoid surprises down the road and dedicate more time to developing new ideas and continuous improvements. Keep reading to learn which areas to prioritize when identifying potential issues and resolutions.

Supply Chain

The first area to explore for possible obstacles should be a familiar answer today: the supply chain. Manufacturers that rely on outside vendors for various resources are unfortunately at their mercy when it comes to completing production on time and hitting deadlines. If the supplier runs into labor shortages, extended shipping times, or their own shortages, your plant may end up facing the consequences. Much of the world has learned just how common these issues can become in the last couple years.

One potential solution to supply chain woes is identifying multiple backup suppliers, and even alternative materials, that your organization can quickly turn to. Building a list of substitutes allows your organization to act quickly and potentially beat a rush of competitors scrambling to find their own last-minute solutions. We saw this situation play out last year in the auto industry, when Toyota overcame semiconductor supply chain issues thanks to its large network of suppliers. You can read more about how Toyota proactively created competitive advantage for themselves in our recent article.

Maintenance

Say your plant manages to get all the raw materials it needs on time…and then your equipment malfunctions unexpectedly. Production delays due to machine breakdowns can be frustrating, but in some cases, they can be avoided. Most pieces of equipment benefit from predictive and preventive maintenance. Performing regular maintenance can extend the life of the machine, improve its efficiency, and reduce the number of interruptions to production. Additionally, predictive and preventive maintenance can be up to 40% more cost effective than reactive maintenance, according to the US Department of Energy.

Creating a data-driven predictive and preventive maintenance program can help avoid sudden stoppages caused by avoidable repairs. Your maintenance team can look for warning signs before a breakdown actually occurs, giving operators the ability to strategically plan the least disruptive schedule for equipment downtime. Plus, with less time spent scrambling to address sudden mishaps, the team can dedicate more time to coming up with new improvements.

R&D

Being proactive doesn’t stop once you’ve addressed day-to-day production problems. It should also continue into long-term planning by committing to research and development to keep your organization on the cutting edge. Dedicating time and funds to R&D can allow you to develop product design improvements, discover new markets, or identify other unique opportunities ahead of your competitors.

As you work through potential proactive improvements to the plant, it can be incredibly helpful to use a virtual plant model, or digital twin, to visualize the effects of each change. A virtual plant model is a digital representation of your plant’s unique capabilities, and it can be temporarily adjusted to explore the ramifications of implementing a process change or adding a new investment. The model can also help managers anticipate problems that may occur under the current plant schedule, ensuring that their team isn’t caught flat-footed and unprepared for upcoming challenges.

VirtECS® is one such tool that offers capacity analysis and virtual plant modeling. The tool has been used by manufacturers across the world to help their employees proactively prevent production challenges, rather than constantly react to them. If you’re interested in learning more about VirtECS®’ unique benefits to manufacturers, check out an overview of our advanced planning and scheduling software.

Improving Lot Cycle Times in Complex Manufacturing Facilities

Improving Lot Cycle Times in Complex Manufacturing Facilities

If your manufacturing organization is striving to become more efficient (and let’s be honest, who isn’t?), one measurement you’ll need to know is each product’s lot cycle time. This term refers to the total time is takes to manufacture one batch of product at the plant. Taking a calculated and responsible approach to reducing lot cycle time has many benefits, including improved productivity, increased output, and fewer resourced used. It also improves on-time delivery for customers, which is key to running a successful long-term business.

Ultimately, shortening the lot cycle time comes down to one primary goal: eliminating opportunities for disruption or variability throughout production. Achieving both objectives is no small task, but by implementing strategic procedures, your plant can reduce cycle time and significantly improve its overall efficiency.

Revamp the Maintenance Program

When your manufacturing plant relies on multiple pieces of equipment to complete production, any unexpected malfunction or breakdown can cause extended delays and increased lot cycle times. Investing in consistent and preventive maintenance of crucial equipment can help the plant avoid hours or days spent waiting for surprise repairs. To build your list of preventive maintenance needs, consult each machine’s manufacturer for the specific activities involved in equipment upkeep and the recommended frequency of maintenance checks. You can then block out time to complete maintenance on a consistent basis, ideally when each machine is already on downtime to lower lot cycle time most dramatically.

To further enhance maintenance efficiency, consider cross training all technicians at your plant so each employee can work on multiples pieces of equipment. No matter who’s on the clock on a given day, they’ll be able to complete all maintenance needs and quickly address any last-minute repairs that still happen to appear.

Reduce Over-Reliance

Variability and disruptions can also emerge when plants are completely dependent on a single piece of equipment. For example, if every product batch must eventually run through one individual machine, any problem or stoppage with the equipment will bring production screeching to a halt. If you’re running a large batch of product at once, there’s an increased chance of encountering even a small interruption. Once that singular machine is thrown off schedule, the total lot cycle time will only grow longer.

If possible, consider allocating funds to add a second (or third or fourth) machine into the process. When both machines are functional, you’ll be able to produce more product in the same amount of time, and if one of them must go under repair, you can still continue production in some capacity. If adding machines isn’t an option, look instead at your existing tools to see if processes could be adjusted to temporarily use alternative equipment in emergency cases. Even if it’s less efficient than the typical machine, slow production is better than no production.

Optimize the Schedule

Once you’ve decided to implement preventive maintenance and reduce reliance on singular machines, it’s time to effectively put those plans into action with an optimized production schedule. An advanced planning and scheduling tool can identify the best times to fit in activities like maintenance while causing as little disruption to regular production tasks as possible. These tools can also seamlessly add in additional plant equipment or shift the schedule to a backup plan, providing an updated and re-optimized plan of attack.

Our scheduling tool, VirtECS®, has been utilized effectively by numerous manufacturers to lower lot cycle times. In fact, VirtECS® improved lot cycle time of a complex global biologics company by 5.9% and reduced their cycle time variability by 22%. If you’re interested in achieving those kinds of result for your plant, you can get in contact with a VirtECS® expert here.