McKinsey: Automated Testing Is at the Center of QC Evolution

Technologies such as the Growth Direct^® System show how pharmaceutical companies can become quality control (QC) leaders, according to one of the industry’s top consultancies.

Even in pharma companies that invest heavily in research or manufacturing, QC micro labs are often the overlooked middle sibling—forced to fight for every penny of operating capital, despite a future that promises tougher inspections and higher costs for every mistake. At Rapid Micro Biosystems we have argued against this outdated mentality for years. In fact, President and CEO Robert Spignesi recently penned a company blog post noting that quality control continues to plague pharmaceutical manufacturing, in contrast to industries that are automating and digitizing critical functions.

“Thousands of highly qualified professionals across the globe are conducting hundreds of millions of tests every year,” Spignesi wrote, “testing the air, water, surfaces, personnel and end products, primarily capturing data manually, on a pen and paper! It should be easy for anyone to understand the errors that can occur with this type of process.”

Now the tide is turning, as illustrated by the McKinsey & Company article, “Digitization, automation, and online testing: The future of pharma quality control.” Authored by McKinsey’s Pharmaceuticals & Medical Products practice, the article predicts dramatic technological changes in QC micro labs over the next five to ten years, leveraging the consultancy’s world-class expertise providing strategic, R&D, operational, and commercial support for leading pharmaceutical and medical product clients around the globe.

A notable feature of the 2019 article, as well as an updated version published in April 2021, is McKinsey’s advocacy of automated compendial testing technologies such as our Growth Direct^® System as the midpoint of a technological evolution that promises to take QC labs in one of three defining directions. If you’re pondering the future of your own pharma lab, you should look carefully at McKinsey’s three “future horizons”—not only considering where you might fit in best, but the kind of help you’ll need to get there.

From Digital Connectivity to Real-Time Release Testing

According to the McKinsey article, “Modern technologies can make QC faster, more agile and reliable, more compliant, and more efficient. By setting appropriate goals, choosing the right technologies, and scaling up quickly, pharma companies can become QC leaders and reap the rewards in the form of speed, compliance, cost savings, and productivity improvements.” Among the many technologies cited are smart eyeglasses that can remind personnel of standard operating procedures, inventory management and Kanban systems, automated sample prep and testing, as well as manufacturing lines controlled by artificial intelligence (AI) and machine learning technologies.

McKinsey’s snapshot of QC paths identifies three evolved lab types.

• Digitally enabled labs use connectivity, advanced real-time data analytics, and ongoing process verification to track trends, prevent deviations or out-of-specifications, and optimize scheduling. As the first stop on McKinsey’s QC spectrum this stage is well within reach of today’s labs, implementing widely available technologies that can have an impact within as little as three months.
• Automated labs take a leap forward by using robots, cobots, or automation technologies like the Growth Direct^® System to perform repeatable tasks such as sample delivery and preparation. Noting that “automated labs can build upon digitization to deliver greater value and higher cost savings,” the McKinsey article cites impressive benefits: cost reductions up to 35%, elimination of up to 80% of all documentation work, up to 90% reduction of investigation workloads, and lead time reductions of 10–20%. Additionally, remote-monitoring and predictive-maintenance capabilities such as those built into the Growth Direct^® platform can decrease downtime while enabling instantaneous microbial detection for environmental monitoring, with potential to reduce overall laboratory lead times 40–75%. And as demonstrated by Rapid Micro Biosystems, these technologies already exist for relatively straightforward adaptation to pharma manufacturing labs.
• Distributed quality control represents a true disruption to traditional quality control approaches, moving nearly all routine product testing to the production line for real-time release testing (RTRT). Distributed QC facilities would primarily add value by reducing the footprint and costs of traditional labs, while enabling pharmaceutical makers to pursue true continuous-manufacturing processes. Work would be carried out in large part by equipment and robots featuring advanced artificial-intelligence capabilities, although labs could continue to perform specialty and stability testing—probably in centralized offsite locations.

In the McKinsey article, automation systems such as Growth Direct^® can be seen as the missing evolutionary link that enables QC microbiology labs rooted in manual compendial processes to become fully digitized and prepared for even smarter and more robust automation in the future. And there has been significant progress. One telling fact is that a majority of the top 20 biopharma companies worldwide have adopted our Growth Direct^® System to automate critical compendial microbiology testing processes, with a number of customers verifying successful regulatory compliance in their own facilities.

There is still a long way to go, however. If you work in pharmaceutical manufacturing, consider your own attitude. Do you think of automation as a luxury, or as a necessary step for long-term industry viability?

Next Steps to Industry 4.0

The road to the future has plenty of potholes, according to McKinsey: cost justification challenges for labs without the right scale or operational setup, lack of a compelling business case, inexperience planning or managing a long-term rollout, insufficient understanding of an acquired system’s full capabilities, and incompatible staff skills and mindset, to name a few. In many cases it comes down to a familiar issue—educating influencers about the need to tackle change before it is forced upon us.

Addressing the industry in his April 2021 blog post, Spignesi noted that the quality control infrastructure in pharmaceutical manufacturing is in critical need of modernization.

“The fourth industrial revolution (Industry 4.0) across other industries has shown that automated systems transform assembly lines and workflows by reducing errors and cost while delivering quality improvements,” Spignesi wrote. “However, for pharmaceuticals, the adoption of automated technologies that improve efficiency, reduce time to detect issues and ensure data integrity can be hindered by the desire to approve investments purely on the basis of traditional labor cost savings and production efficiency gains. Some of the softer, but arguably more important, factors like reduction of errors or investigations, data integrity, improving manufacturing capacity, saving batches of life-saving drugs and vaccines are often underrepresented in the business cases.”

Some leading pharmaceutical companies are indeed beginning to invest more heavily in automating their QC labs to reduce operating risk and accelerate delivery of medications to patients. But to fully impact global supply chains of critical vaccines, therapies, and other medications, broader adoption will be needed.

If you are just getting started on your own journey to the future, McKinsey suggests these tips:

• Test several use cases and technologies quickly to find the best ones for your lab type.
• Create lighthouse QC labs to showcase potential benefits.
• Go for innovations with the greatest immediate impact and roll them out quickly across multiple sites, instead of getting bogged down at one site equipped with every bell and whistle.
• Establish a clear target and business case for each lab early on, tracking the value capture along the way and reinvesting the savings into new upgrades.
• Aim for the highest-value horizon that can be justified, so you won’t need upgrades again as soon as you open your doors.
• Start building the needed talent base and skills early on, investing in high-potential employees who will be able to support faster scale-up.

Automating your traditional compendial processes is a good example of a proven “gateway” innovation that can prepare your organization for enhanced digitization and other advances to come. Why not contact Rapid Micro Biosystems today to discuss any questions or concerns you might have? Our experience helping customers evaluate current QC performance and plan their own QC lab of the future can go a long way toward ensuring that your next step is in the right direction.

Learn more about the Growth Direct^® System and how we can help you start your own automation journey. CONTACT US TODAY.

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