Antibiotic-resistant bacteria and emerging viruses are a rapidly increasing threat to the global health care system. About 5 million deaths each year are linked to antibiotic-resistant germs, and more than 20 million people died during the COVID-19 virus pandemic. Empa researchers are therefore working on new, urgently needed strategies to combat such pathogens. One of the goals is to prevent the spread of resistant pathogens and novel viruses with smart materials and technologies.

Surfaces that come into constant contact with infectious agents, such as door handles in hospitals or equipment and infrastructure in operating theaters, are a particularly suitable area of application for such materials.

An interdisciplinary team from three Empa laboratories, together with the Czech Palacký University in Olomouc, has now developed an environmentally friendly and biocompatible metal-free surface coating that reliably kills germs. The effect can be reactivated again and again by exposing it to light. The study is published in the journal EcoMat.

Biocompatible and effective

“The new material is designed to kill microorganisms locally and quickly,” explains Giacomo Reina from Empa’s Nanomaterials in Health Laboratory in St. Gallen. A basic matrix of polyvinyl alcohol, a biocompatible plastic that is also used in the food industry, was used for this purpose. Embedded in this matrix is specially synthesized graphenic acid, which is ideally suited as an antimicrobial coating due to its chemical properties.

Its full potential can be exploited by using near-infrared light. As soon as the composite material is irradiated, it unfolds its dual strategy: First, it absorbs the energy of the infrared light and converts it into germicidal heat. It also stimulates the formation of oxygen radicals, which cause additional damage to the pathogens.

Another advantage here is that this strategy is completely different from the mode of action of conventional antibiotics. The material thus offers continuous protection against a broad spectrum of microorganisms without contributing to the development of resistance. “Our laboratory experiments have clearly confirmed the effectiveness of the antimicrobial material against various bacteria and viruses,” says Reina.

Application for dentistry

An initial application for the antimicrobial coating is currently being developed for dentistry. To this end, Empa researchers are working together with the Center for Dental Medicine at the University of Zurich on a dental splint that kills microorganisms in the oral cavity.

The microbial flora in the mouth is a particularly unpleasant opponent in the fight against infectious agents: Complex communities of bacteria cavort in inaccessible niches, embedded in a self-produced mucous matrix. Antibiotics and disinfectants barely penetrate these resistant biofilms. This allows the germs to ruin teeth unhindered or even lead to extensive infections in the body.

The interdisciplinary team led by Reina is therefore working on a plastic splint into which nanomaterials such as graphenic acid can be stably integrated. As near-infrared light can penetrate the tissue several centimeters deep, the splint can be placed in the oral cavity and activated from the outside by a light source, over and over again.

In recent decades, sensor-less cars that rely on human decision-making have evolved into self-driving taxis that arrive on demand. Beate Mueller-Tiemann, PhD, CTO of the global life sciences company Cytiva, points to these autonomous vehicles as an analogy for the digitization of the biomanufacturing industry, which has recently culminated in a new era known as “Bioprocess 5.0.” This latest generation integrates advanced digital technologies, automation, and sustainability principles to streamline the production of biological products, such as pharmaceuticals, vaccines, and enzymes.

“Pharma companies like to use the term ‘smart manufacturing,’ in which operations are driven not only by serendipity and diligent work, but by data-driven insights and adaptive process control,” explained Mueller-Tiemann in an interview with GEN.

5.0 pillars

The hallmarks of Bioprocess 5.0 include the incorporation of artificial intelligence (AI) tools to optimize and control of bioprocess parameters in real-time to support improved quality and standardization. For example, virtual replicas that simulate processes, known as “digital twins,” can test scenarios while minimizing risk to actual production runs, thereby increasing process consistency, limiting error, and increasing speed-to-clinic.

“Successful bioprocessing pipelines will maintain a focused approach, in which upstream and downstream efforts are connected with a focus on yield, robustness, and reproducibility,” Sebastián Arana, head of process solutions life science business of Merck KGaA, Darmstadt, Germany. told GEN. He emphasizes that data should be leveraged at every stage for faster decisions and fewer batch failures.

Arana also notes that sustainability goals remain at the forefront of Bioprocess 5.0, with the use of renewable energy being one of the most impactful movements to decrease the footprint of bioprocessing production. MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. It currently operates with 78% renewable electricity and is aiming to increase that value to over 90% in Q1 of 2026.

“The next chapter is the transition to focusing on reducing the footprints of the individual products and increasing the intensification of bioprocessing,” explained Arana. Aligned with this goal, MilliporeSigma is driving a Design for Sustainability program into the company’s R&D pipelines. The program develops eco-friendly and disposable products.

Sigma Mostafa, PhD, CSO at KBI Biopharma, highlights the incorporation of human-centric automation within Bioprocess 5.0, in which digital tools are designed to work with humans to enhance manufacturing capabilities. She says the emphasis remains on scientists working with software as opposed to machines replacing humans.

“You can come up with the best automation or machine-learning solution, but it may not take into account new sustainability solutions or how the industry and market are changing. 5.0 brings that holistic perspective,” Mostafa said. She lists particle characterization as an example process that bridges the balance between human decision-making and digital tools.

While machine-learning models can improve the precision of comprehensive analyses of the physical and chemical properties in a drug formulation, effectively evaluating the safety, efficacy, stability, and manufacturability of a drug requires living scientists to leverage existing knowledge from the literature to assist interpreting model results.

Scaling personal therapies

Mueller-Tiemann looks to CAR T manufacturing for autologous cancer cell therapy as a prime example of the need for autonomous systems. Specifically, as many CAR T therapeutics are moving toward autoimmune diseases with larger patient populations, manufacturers and technology providers will need to develop solutions that scale to that expanded reach.

Aligned with this goal, Cytiva announced a partnership in January that combines the company’s manufacturing technologies with the robotic platform of Cellular Origins, a cell therapy-focused manufacturing company, to enable production of cell and gene therapies for larger populations.

The recent story of Baby KJ, an infant who became the first patient to receive a bespoke gene editing therapy to treat his severe metabolic disorder, has also added new hope for scaling personalized therapies.

KJ was diagnosed with severe carbamoyl phosphate synthetase 1 (CPS1) deficiency, an often fatal urea cycle disorder with an estimated 50% mortality in early infancy. Given these urgent timelines, the FDA granted accelerated approval for his experimental bespoke base-editing therapy manufactured by Danaher-owned companies, Aldevron and Integrated DNA Technologies.

According to Kiran Musunuru, MD, PhD, one of the lead physicians overseeing KJ’s case and professor of translational research at Perelman School of Medicine at the University of Pennsylvania, the therapy’s cost was “not as expensive as you might think.” While the traditional approval route for gene editing therapies requires years of rigorous studies to demonstrate safety and effectiveness, the fast timelines to address KJ’s urgent health status significantly lowered costs compared to standard drug development. However, the bioprocessing industry is still wrestling with establishing a reproducible scalability blueprint that would support similar cases beyond KJ’s treatment.

When reflecting on the broader impact of single patient cases, Peter Marks, MD, PhD, former director of the Center for Biologics Evaluation and Research (CBER) at the FDA, urged regulatory approaches to leverage the information that is used repeatedly from product to product, while allowing for the required customization, such as guide RNA in the case of CRISPR constructs.

“Facilitating such a process could transform N-of-1 therapy into N-of-many therapies, thus leading to commercial viability of these products for rare diseases—a development that would ultimately benefit many persons with great unmet medical need,” Marks wrote earlier this year in an editorial in The New England Journal of Medicine.1

Complex molecules

The complexity of biomolecules has greatly evolved from the advent of monoclonal antibodies nearly half a century ago. Modalities such as antibody drug conjugate (ADC)-based drugs, a class of cancer therapies that combine the targeting ability of antibodies with the cell-killing power of cytotoxic drugs, require additional regulatory and manufacturing considerations, which can slow uptake. Despite adoption challenges, Mueller-Tiemann emphasizes that evolving therapies will mature and are here to stay.

“Complex new biologics, like ADCs, now mean we have a need for our scientists who have both a biologics and chemistry understanding because you have to be able to conjugate, purify, and analyze these materials to get the right product,” explained Mueller-Tiemann.

Aligned with this trajectory, Enhertu, an ADC-based blockbuster drug that first received FDA approval in December 2019 for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, achieved global sales exceeding $1.6 billion in 2022.

Back at Millipore Sigma, the manufacturing of ADCs has advanced thanks to an alliance for Antibody Drug Conjugate Drug Substance and Drug Product Manufacturing Services with Simtra Biopharma Solutions. Announced in June, the partnership creates a turnkey offering for biopharmaceutical companies seeking ADC and bioconjugation, linker/payload manufacturing, drug product formulation development, and fill-finish capabilities.

“Connecting the bioconjugation and fill-finish steps will be a value-add for our clients, meeting their ambitious timelines and allowing the broadest number of patients to benefit in the fastest and safest possible way,” Benjamin Hein, head of life science services, life science business of Merck KGaA, Darmstadt, Germany, told GEN.

Taken together, Mostafa emphasizes that Bioprocess 5.0 is not being applied to “local optima” that focus on a specific facility or equipment, but is aimed at broader solutions.

“Have we improved our sustainability metrics and overall human experience? Is there a clear definition of the value proposition for humans? When we can articulate these points and people’s roles evolve, that’s where 5.0 truly will kick in,” says Mostafa.

Eli Lilly said it has chosen a location near Richmond, VA, for its planned $5 billion manufacturing plant that will be the first-ever dedicated, fully integrated active pharmaceutical ingredient (API) and drug product facility for the pharma giant’s bioconjugate platform and monoclonal antibody portfolio.

Lilly has chosen the West Creek Business Park in Virginia’s Goochland County for the facility, which will manufacture APIs for therapies designed to treat cancer, autoimmune diseases, and other disorders—including antibody-drug conjugates (ADCs).

The planned Goochland County facility is the first that Lilly has revealed since announcing in February that it would roughly double—to more than $50 billion since 2020—its planned spending on U.S.-based manufacturing by building four new facilities. At the time, Lilly said three of the facilities would be API manufacturing sites, while the fourth would extend the company’s global parenteral manufacturing network for future injectable therapies.

The locations of the other three sites will be announced later this year, Lilly said.

“Our investment in Virginia underscores our commitment to U.S. innovation and manufacturing—creating high-quality jobs, strengthening communities, and advancing the health and well-being of Americans nationwide,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “By expanding our domestic capacity, we’re building a secure, resilient supply chain that delivers for patients today and supports the breakthrough medicines of tomorrow.”

Ricks is among biopharma CEOs whose companies have announced plans for a combined $290 billion-plus in new and renovated facilities. While primarily focused on manufacturing, some of the companies have unveiled projects intended to bolster R&D and other operations.

The announcements have trickled out in recent months as President Donald Trump’s administration has pressed the biopharma industry to make more of its products in the United States, in part by threatening to impose tariffs on pharma imports. Ricks is a Trump ally who publicly credited the president’s earlier 2017 tax cuts with enticing them to build their manufacturing sites in the United States.

“We will continue to bring more capacity online in 2025 and expect our production capabilities to increase further,” Ricks told analysts on August 7 on the company’s quarterly earnings call following the release of second-quarter results. On the call, he said Lilly planned two manufacturing site announcements during the current third quarter—the Virginia site and a site yet to be announced.

Choosing Virginia

Lilly is the second pharma giant to announce plans for a multi-billion-dollar manufacturing plant in Virginia in recent months. The first was AstraZeneca, which in July joined Gov. Glenn Youngkin (R) in revealing plans for what the company said will be its largest-ever manufacturing facility at a site in the Old Dominion State—later revealed to be within Albemarle County, near Charlottesville, VA.

Virginia is part of the BioHealth Capital Region, along with Maryland and Washington, D.C. The region ranks number three in GEN’s most recent A-List of Top 10 U.S. Biopharma Clusters.

Lilly said it chose Goochland County from “several hundred” applications seeking the API facility based on criteria that included, but were not limited to, the potential of the workforce in Greater Richmond, ready access to utilities and transportation, favorable zoning, and economic incentives.

Youngkin announced that the state’s public-private economic development agency, the Virginia Economic Development Partnership, worked with Goochland County and the General Assembly’s Major Employment and Investment (MEI) Project Approval Commission to secure the project for Virginia.

Lilly will be eligible for an MEI Commission-approved special appropriation of up to $130 million, subject to approval by the Virginia General Assembly. The $130 million package was based on the pharma giant’s original plans for the site, which called for investing more than $2.148 billion and creating 468 jobs.

Lilly now expects the project to generate 1,800 construction jobs, followed by more than 650 new high-paying jobs that will include positions for engineers, scientists, operations personnel, and lab technicians. The company employs more than 49,000 people worldwide, of which roughly half (22,000 employees) are based in the United States. Lilly has manufacturing facilities in nine countries, including the United States, where it has sites in its headquarters state of Indiana, North Carolina, as well as New Jersey, Wisconsin, and Puerto Rico.

Lilly plans to build the Goochland County API site within five years.

“This isn’t just another manufacturing site—it represents a significant milestone for Lilly, as we begin building our first bioconjugate facility,” said Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations. “With this cutting-edge site, Lilly is setting a new benchmark in bioconjugate innovation, advancing technologies that will expand what’s possible for patients.