At The MFG Meeting 2026, discussions about the future of manufacturing extended well beyond traditional production and into one of the fastest-evolving sub-industries: advanced biomanufacturing, which is creating new opportunities for traditional manufacturers.
Julie Lenzer, who served as chief innovation officer at the Advanced Regenerative Manufacturing Institute (ARMI) for the past four years, provided a high-level introduction to advanced biomanufacturing, where biology and manufacturing intersect to address some of the most complex challenges in healthcare. She highlighted the technologies, challenges, and opportunities within the industry, and where manufacturing capabilities could play a significant role in enabling future advancements.
A Growing Need in Healthcare
Lenzer opened by framing the broader healthcare need. In the United States, 17 people die each day waiting for an organ transplant, due to limited supply and growing demand tied to chronic disease. Regenerative medicine and biomanufacturing aim to address this need by developing engineered tissues and cell-based therapies to repair or replace damaged biological functions, and may, in the future, provide an alternative to donor organs. In some cases, these therapies are built from a patient’s own cells, reducing the need for long-term treatments and improving outcomes.
A Market in Transition
As technology advances, so does the market. Advanced biomanufacturing, including biologics, cell and gene therapies, and related technologies, continues to expand globally – with strong growth in the U.S. that is supported by investments in research, infrastructure, and commercialization.
While therapies are progressing through clinical trials and approaching broader adoption, the infrastructure needed to manufacture them at scale remains underdeveloped. This dynamic is creating a gap between innovation and implementation that traditional manufacturers are uniquely positioned to address.
“Manufacturing is the way that science actually gets to the masses,” Lenzer noted, emphasizing the importance of production systems in translating discovery into real-world impact.
Where Manufacturing Meets Biology
Unlike traditional manufacturing environments, biomanufacturing introduces new variables. Living cells are sensitive, production can take weeks, and outcomes may vary based on small changes in environmental conditions. Many current production methods remain manual and difficult to scale, contributing to cost and consistency challenges. These constraints are driving the need for more controlled and scalable production systems, many of which align well with existing manufacturing capabilities.
Automation technologies such as robotics, closed systems, and modular platforms are being explored to improve repeatability and reduce contamination risks. Advances in materials, including single-use systems and specialized polymers, are supporting sterile and controlled environments. Emerging techniques like 3D bioprinting and microfluidics are expanding how biological products can be produced.
Rethinking Quality and Control
Regulation is another area undergoing change. Traditional manufacturing relies on consistency across a production line, but cell-based therapies – especially personalized treatments – introduce variability. That shift has prompted efforts to establish new quality frameworks, including identifying critical quality attributes and developing predictive quality management tools, as well as nondestructive measurement and control procedures.
AI is expected to play an increasing role in this shift. Data analytics and AI are being explored for process monitoring, identification of key variables, and predictive quality management tools.
Supply Chains Under Pressure
Biomanufacturing supply chains present additional challenges compared to other manufacturing supply chains. Products are often fragile, temperature-sensitive, and time-critical. In some cases, they are tailored to individual patients, requiring precise tracking and handling throughout the process.
These challenges are already evident in healthcare logistics. For example, a portion of donor organs do not reach recipients due to logistical constraints, rather than a lack of availability. This matter further reinforces the need for improvements in packaging, preservation, and supply chain logistics.
For manufacturers, this need introduces opportunities in areas such as advanced packaging, sensing and monitoring technologies, and integrated logistics solutions.
An Open Field for Innovation
Across biology, regulation, and supply chain, a common theme emerges: While the technology is advancing, manufacturing systems are still catching up.
This transitional period creates a range of potential entry points for manufacturers. Many of the capabilities required, including automation, materials engineering, precision control, data systems, and logistics, are already well established in other sectors. The opportunity lies in adapting those capabilities to meet the specific requirements of biomanufacturing.
Organizations such as ARMI are working to support this transition. With more than 200 members nationwide, ARMI provides access to funding opportunities, shared facilities, and collaborative networks designed to help companies test and scale new technologies.
As manufacturing continues to evolve, advanced biomanufacturing represents an area where multiple disciplines converge by bringing together science, engineering, and production in new ways.
For manufacturers, the sector offers both complexity and potential. Identifying where existing technologies align with emerging needs is a critical first step toward engaging with the biomanufacturing sector.
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