Automation Is More Than a Trend: It’s How the Global Pharmaceutical Industry Future-Proofs Its Operations
"In 2021, it’s no longer enough to look at progress one year at a time. Rapid automation makes it possible to take the long view."
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RAPID MICRO BIOSYSTEMS and GROWTH DIRECT are registered trademarks of
Rapid Micro Biosystems, and the company logo is a trademark of Rapid Micro Biosystems
President and CEO
- Rob Spignesi, President and CEO
3 Market Drivers Reshaping How Pharma Leaders Use Rapid Automation to Stay Competitive:
Public Scrutiny and the Need for Speed
Labor shortages, data integrity requirements, and the rapid growth of biologic and cell and gene therapies are putting unprecedented pressure on legacy micro QC infrastructure. What was once seen as a trend is now recognized as an essential transformation that will enable QC micro labs to keep pace with changing global health demands and regulatory compliance.
Rapid automation combined with the digitization of results speeds time-to-insight with full data integrity and compliance at every step. Pharmaceutical manufacturers implementing such technologies can reduce the cost of labor, increase capacity of existing manufacturing plants and scale-ups while creating consistency across all testing sites.
Implementation of these technologies is no longer a matter of why but a matter of when. Waiting on the sidelines only puts companies farther behind on in terms of their ability to retain talent, secure data integrity, and compete with more efficient, future-focused companies.
If you need help formalizing a digital transformation strategy for your QC micro lab, contact the experts at RMB directly through our website or simply call 978-349-3200.
Covid-19 has put intense focus on the pharmaceutical industry and its ability to quickly respond to global health needs, but the push for greater efficiency is not solely about responding to the pandemic, which hopefully will no longer be a factor in coming years. A significant, structural factor is new cell and gene therapies and other biologics that are rapidly changing the face of healthcare. Many pharmaceutical companies are playing catch-up to ensure they can deliver on the promises of such therapies. Rapid automation technologies that were once considered a “nice-to-have” have become absolutely essential for keeping up with the accelerated pace of manufacturing.
Rapid Micro Biosystems President and CEO, Rob Spignesi says, “The needs of modern pharmaceutical manufacturing are outstripping the capabilities of the legacy, 140-year-old microbial QC methods. The current structure of most QC micro labs makes them ideal candidates for automation to drive efficiency, improved data integrity and business growth.”
Covid-19 may have shined a spotlight on the pharmaceutical sector’s lack of digital maturity, but this was not a new problem rather it was highlighting a problem that already existed. Pharmaceutical manufacturers that cling to outdated methods are incurring unnecessary brand, operational and data integrity risk.
Regulatory Intolerance for Manual Errors
Data integrity should be the number one priority for QC micro labs that want to remain effective and operational. Without it, they will struggle to stay competitive and will ultimately be replaced.
Regulators no longer have patience for data integrity issues caused by manual errors and are making it known they expect QC micro labs to establish a higher level of data integrity. Since 2015, regulators have been issuing guidance documents and directives warning of the need for greater data integrity in the QC micro lab, and specifically noting that manual observations in critical quality tests represent a significant risk. Warning letters citing data integrity issues tripled in the three years following that guidance.
Dr. Janet Woodcock, Director for the Center for Drug Evaluation and Research at FDA, called out companies for not using technologies that are up to date, making it clear that the centuries-old, traditional QC culture method is antiquated and should be replaced. She said, “Unfortunately, incentives today are not high enough for many manufacturers to establish mature quality management capabilities. As a result, drug manufacturers are more likely to keep costs down by minimizing investments in manufacturing quality, leading to quality issues that can trigger supply disruptions and shortages of needed medications.” (FDA, 2019).
Rapid automation solutions that replace slow, error-prone, manual QC processes allow manufacturers to confidently accelerate bioprocessing, maximize capacity, and reduce operational risk, manual errors and downtime—all while maintaining the highest standards of data integrity. Such technologies can help organizations modernize their QC micro operations, enable their teams to meet regulators expectations, sustain competitive advantage, and, ultimately, serve patient needs and safety. Rapid automation solutions deliver an across-the-board advantage by providing fast, secure results through, paperless digitization. This approach is the gold standard in data integrity for future-ready organizations.
Labor and Talent Shortages in the QC Micro Lab
Even before Covid-19, the pharmaceutical talent pool was too shallow to accommodate the growing needs of world health. Now, a recent article in the Wall Street Journal is bringing heightened attention to the issue. The global push for Covid-19 vaccines is creating a hiring crunch for pharmaceutical companies and contract-manufacturing companies alike, and more than 5,000 open jobs at the world’s ten largest companies are still waiting to be filled.
This heightened competition for the best and brightest combined with the practical need for social distancing in the QC micro lab makes it imperative to reduce staff even as the speed of manufacturing accelerates. Rapid automation technologies help by eliminating up to 80% of manual documentation work and 75% of manual testing steps while enabling pharmaceutical companies to easily audit productivity and safety standards—even remotely.
Brands that are still mired in manual operations in the QC micro lab will have a hard time attracting and retaining top talent who are in demand and looking to join the most innovative, forward-thinking companies.
About the Author
President and CEO of Rapid Micro Biosystems
Rob has more than 20 years of leadership experience. Before joining Rapid Micro Biosystems, he was Vice President and General Manager, Americas, for the microbiology division of Thermo Fisher Scientific.
Previously, Rob was the VP of Global Strategy, Marketing, and Business Development for Fisher Scientific. He’s also held senior positions at McKesson Corporation and its affiliates, including EVP Operations and Development, and National vice President Sales and Business Development.
Rob holds a BS in Economics from the United States Military Academy at West Point and holds an MBA from Columbia University where he was a Dr. Donald Bibeault Scholar.
for pharmaceutical to rethinkhow they manage risk and achieve their financial goals while delivering safe, effective medications to an ever-growing world population. The number of companies willing to accept outdated processes and methods for QC micro lab testing is declining. In fact, the majority of the top twenty leading pharmaceutical companies are adopting rapid QC micro automation to future-proof their output and protect the value of their brands.
he overpowering pressure of global health demands along with the
breakneck speed of scientific innovation have made it necessary
Rapid automation methods that digitize results can make dramatic improvements by cutting the time needed to complete a test by half while enabling steps that are traditionally run in sequence to be executed in parallel, saving time and eliminating the risks of human error. Quality control measures that monitor workflows and detect microbial contamination will continue to be mission-critical, particularly in enabling increased speed and capacity.
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