Snapshots of an Industry in Transition

In-person events are back in full swing after Covid-19, and it’s exciting to see big crowds again. Here are five key takeaways based on what we’re seeing at venues worldwide, promising major changes ahead for pharmaceutical manufacturing.

Digitalization is increasing, but incomplete. For years RMB has championed seamless integration of automated QC workflows, and it appears that many pharma and medtech companies are finally making the replacement of paper-based processes a high priority. In fact, a recent MasterControl study of 152 manufacturing professionals (download required) finds that 65% are accelerating the move to connected manufacturing technologies. Even more significant, 63% credit competitive advantage as the biggest reason for digitalizing. That’s a major change in thinking.

But there are growing pains ahead. Only 9% of survey respondents with a manufacturing execution system (MES) said that all their production lines share data electronically, and only 55% of all respondents have a formal digital transformation plan in place. A remarkable 90% admit to significant gaps in their digitized processes, or no digitized processes at all! This is consistent with the widespread grumbling we’ve heard about siloed production systems, missing or non-compliant data, poor traceability, and still too much paper on shop floors and in corner offices.

If your own organization is uncertain about the next step, check out this article mapping the journey to digital transformation. Our experience assisting Top 20 pharma companies to automate traditional QC microbial testing and integrate it with lab information management systems (LIMS) can help you forge a critical link for Pharma 4.0™ connectivity.

Automation could be the gateway to newer innovations. Analysts at firms such as McKinsey & Company have been predicting dramatic technology changes in the next decade for pharmaceutical quality control, once automation eliminates the weak link of manual, paper-based processes. Now we’re hearing discussions of exciting technologies enabled by the lab of the future – including these innovations identified by veteran industry thought leader Tim Sandle:

• “Lab-on-a-chip” biosensors that could be used for immediate detection of different organisms, assessing how they interact with varied compounds, and enabling dozens of tests to be performed simultaneously
• Enhanced microbial identification featuring surface-enhanced Raman spectroscopy (SERS), eliminating the need for separation procedures while enabling new drug development tools that classify bacterial spectra by isolate, empiric treatment, and drug resistance for easier creation of susceptibility profiles
• Next-generation LIMS providing greater database flexibility and connectivity with a wide range of lab instruments
• Use of artificial intelligence (AI) for everything from insights and advice on microbial growth patterns, to validation support of imaging analytics, as well as faster processing of slides and culture plates

Regulatory concerns are driving firms to minimize human intervention. As predicted in our Annex 1 preview back in 2021, developers and makers of sterile pharmaceuticals are responding to evolving guidelines that advocate automated quality control technologies as a means of minimizing risk from microbial, particulate, and pyrogen contamination. At numerous industry events we’re seeing more emphasis on automation, robotic handling, and rapid microbial methods (RMM) technologies such as those integrated in our Growth Direct® System.

Other technologies are also benefiting from increased demand for sterile and contaminant-free products. This year’s INTERPHEX event, for example, was notable for the large number of companies exhibiting isolator products, which have been endorsed by regulatory bodies for protection against contamination by personnel, materials, and surrounding environment. That signals greater use of isolators in the future, with recent research projecting 6.5% annual growth of pharmaceutical isolators in the United States through 2025.

With new therapeutics come new commercialization challenges. Explosive growth in the number of advanced therapy medicinal products (ATMPs) being pipelined is forcing leading-edge companies to be equally innovative in their commercialization. At this year’s Cell and Gene Therapy Development Congress in Dublin, we met QC microbiologists whose products currently cost upward of a million euros per dose, due to painstaking manual processes and extreme speed/safety demands; their ability to scale up from a few batches for clinical trials to much larger manufacturing volumes will require robust automated platforms that can help them to:

• Decrease process times
• Increase speed of testing
• Shrink their production footprint
• Reduce dependence on highly trained personnel
• Lower upfront costs and drive savings over time

One solution is totally automated cell and gene therapy manufacturing, with some industry experts predicting that “lights-out” facilities using robots for every stage from goods-in to goods-out could become reality by 2030. In the meantime, our Growth Direct® System is helping to automate compendial methods and streamline data integrity practices for ATMP manufacturing sites around the globe. To learn more, check out our cell and gene therapy whitepaper or read RMB’s interview with quality expert Irving Ford.

Partnerships with contract organizations are on the rise. CRB, a leading facilities design firm, surveyed nearly 500 life science leaders for its 2022 Horizons: Life Science report (download required). More than half said they plan to rely on contract manufacturing organizations (CMOs) within the next five years, citing increased pipeline complexity and a need for greater resilience and scalability. In addition, the U.S. Food and Drug Administration (FDA) is promoting contract organizations for the complete outsourcing of platform manufacturing, enabling partnerships that could lead to true “plug and play” production lines.

Because contract organizations must manage high volume demands and tight timelines with little margin for error, many have been quick to automate contamination detection workflows that were previously a source of bottlenecks and human error. The result is not simply improved efficiency, but a source of competitive advantage with sponsors seeking a “de-risked” pipeline.

Want to Learn More? Look for Us at an Event Near You! Rapid Micro Biosystems personnel attend industry events worldwide, and we would love the opportunity to talk about challenges you face with your quality control workflow. Check out our calendar of events for where we’ll be next, or contact us today.