How Is Industry 4.0 Changing the Biopharma Industry?Follow article
Industry 4.0 represents a relatively recent phase in the industrial revolution that relies heavily on advancements like real-time data, connected sensors, and automated machinery. The biopharmaceutical sector did not feature among the industries that moved quickly to implement the related technologies.
However, many company decision-makers now realize that these technologies can bring a wide range of benefits. Here are some of the numerous advantages that Industry 4.0 upgrades bring to the biopharma sector.
Reducing Critical Equipment Downtime
Equipment malfunctions can prove exceptionally costly for biopharmaceutical companies. In addition to production disruptions caused by such failures, these issues might lead to product contamination that could harm consumers if undetected before marketplace distribution.
At one of its Dutch facilities, Johnson & Johnson developed an Industry 4.0 solution to limit the mechanical failures associated with 10 autoclaves that sterilize auxiliary equipment. The company built digital twin models of three autoclaves and used them to predict maintenance needs.
An astounding 11 million records provided historical data from about six to seven years of autoclave operations. Autoclaves have pressure controls, safety valves, and seals between a removable lid and the autoclave’s cylindrical body. The digital twins and accompanying data helped the company become aware of maintenance needs before they caused unplanned shutdowns.
Facilitating Faster and More Successful Product Development
While the COVID-19 pandemic presented opportunities for biopharma executives, it also illuminated vulnerabilities that Industry 4.0 advancements could address. Data analytics tools accelerated decision-making and product development. They help biopharma teams learn about the most likely effective outcomes. Then, companies devote more resources to projects with the highest likelihood of fruitfulness.
Kathy Brunner, president and CEO of Acumen Analytics, used a recent interview to explain some of the changes she’s seen. “Industry 4.0, Biopharma 4.0, Life Sciences 4.0, Lab 4.0, all are contributing to ramp capacity to identify, produce, and ultimately distribute vaccines necessary to flatten the curve and turn the course of the COVID-19 virus,” Brunner clarified.
Data and tools to process the information also speed the development of new treatments, even before clinical trials occur. “Advanced analytics and data visualization of expected human response to potential vaccines allows researchers to conduct tests at scale even before vaccine candidates are administered to patients,” Brunner said.
One source indicates that data analytics for research and development could add $60 billion in value to biopharma companies. That finding shows how opportunities exist beyond COVID-19 vaccines.
Maintaining Appropriate Operating Environments
Biopharmaceutical companies feature tightly controlled environments. Failure to monitor them and promptly address any issues could lead to batch contamination and recalled products.
Fortunately, Industry 4.0 tech has proven instrumental in increasing visibility and giving reliable data. For example, some water monitoring systems collect data thousands of times per day, helping companies improve operations.
These offerings can also give alerts about deviations from the norm. For example, a common misconception is that potable water cannot contain coliform bacteria. However, tolerances exist depending on the number of samples collected monthly. If a system collects at least 40, no more than 5% can have coliform bacteria. However, if the setup gathers less than that, it can only identify one positive sample to stay within limits.
There are other specifications, too. For example, samples cannot contain faecal coliforms or E. coli at all. A thorough environmental monitoring program is crucial for ensuring biopharmaceutical plants operate smoothly and do not put people in danger with tainted products.
However, there is no universal approach to use. Contamination risks can vary based on the room and manufacturing processes used. However, connected sensors facilitate personalizing the risk management process to catch and mitigate problems.
Increasing Productivity Levels
Evidence also suggests Industry 4.0 technology could be a significant productivity booster. That’s especially true during the research and development phases. For example, some pharma companies have lab technicians record information in digital, cloud-connected notebooks. Then, there is a reduced chance of data loss, and it’s easier to share information between relevant parties.
Similarly, a lab technician could remotely control connected equipment from across the room by using an app. That advantage saves them time and extra steps.
Error reduction is another benefit of Industry 4.0 that could raise productivity levels. Even the most conscientious humans make mistakes. However, many smart systems allow setting parameters and triggering prompts so people don’t forget steps or make other blunders that could result in extra work.
Industry 4.0 tech can also improve processes to raise output. In one case, an oral solid dosage manufacturer sought to enhance a two-step coating process. Researchers ran 5,000 simulations to see which parameters maintained excellent quality but reduced the coating time. These investigations led to a 25%-51% decrease in the coating timeframe. Moreover, the company utilized real-time monitoring to identify and fix any issues that appeared during production.
Ensuring the Safe Delivery of Manufactured Goods
Industry 4.0 brings positive biopharma developments at the plant level. It can also help company leaders track shipments once they leave facilities.
Much of the buzz surrounding the Pfizer-BioNTech mRNA COVID-19 vaccine related to the product’s stringent storage requirements. The manufacturer confirmed that it would deploy proprietary reusable boxes containing up to 5,000 doses each. Those containers feature technology to monitor their locations and temperatures.
That vaccine requires extremely cold temperatures, and improper storage or handling could ruin full batches and disrupt vaccination schedules. As more vaccines get approved, those may require specific temperature ranges, too. However, not all companies will devote resources to developing in-house distribution methods.
A manufacturer that makes a connected storage solution to accommodate all of the leading COVID-19 vaccines aims to help. It claims to cut the vaccines lost in transit to just 0.1%, whereas the rate is normally as high as 10%. The container, which cools to as low as -80 degrees Fahrenheit, and has embedded communication systems, also enables direct delivery from the manufacturer to the facility handling vaccine administration.
Industry 4.0 Enhances the Biopharma Sector
Perhaps you’re not ready to use Industry 4.0 solutions in your facility. Moving to implement them requires time, financial resources, and a practical strategy for success. However, these examples should motivate you to continue exploring the possibilities of advanced technology and learning about how it could make your processes and products better.