AI, Digitalization, and Advanced Synthesis in Pharma Manufacturing

In this episode, we speak with François Ricard, Christian Seufert, and Jan Vertommen from Lonza’s Advanced Synthesis platform about how AI-driven process innovation is shaping the development and manufacture of complex molecules.

Tune in to hear how pharmaceutical manufacturing is moving toward more data-driven approaches. From AI-based route scouting to process optimization, our guests discuss how these tools are being applied in practice to improve decision-making and reduce uncertainty in early-stage processes.

They also explore advances in conjugation and bioavailability enhancement, including how new approaches can help identify likely solid-state forms. Together, these innovations support the development and manufacture of increasingly complex, difficult-to-make molecules.

Innovating Drug Development and Manufacturing: How External Collaborations Shape the Future of Biotherapeutics

In this episode of A View On, we speak with Andrew Brown, R&D Director at Lonza’s Integrated Biologics, and Zara Asgharpour, Director of External Innovation in Integrated Biologics, about how evolving molecular formats and external innovation are transforming the way biotherapeutics are developed and manufactured.

The world of biotherapeutics is in constant evolution, with new molecular formats, scientific insights, and strategic partnerships shaping the medicines of tomorrow. These increasingly complex biologics require new approaches in development and manufacturing, from developing advanced characterization methods to flexible, innovation-driven platforms.

Traditionally, biomanufacturing relied on well-established monoclonal antibodies and incremental process improvements. Today, developers are increasingly bringing a far broader range of modalities into the pipeline, each with unique scientific and manufacturability challenges. Meeting these demands requires both internal expertise and collaboration with external innovators.

Advances in technology and science are reshaping the design, production, and innovation of biomolecules, making agility, partnerships, and new technologies key to the development of modern biologics.

Process Analytical Technologies: Real-Time Insight for Smarter Manufacturing

In this episode, we speak with Carrie Mason, Thad Webster, and Ryan McDougall from Lonza’s PAT Center of Excellence about how Process Analytical Technologies are transforming the way biologics are developed and produced.

This episode of A View On takes us inside the manufacturing suite, where data, sensors, and decision-making converge in real time. Our guests explain how process analytical technologies (PAT) bring advanced analytics and spectroscopy directly into bioprocesses, allowing operators and scientists to “see” what’s happening inside a bioreactor without taking samples out.

Traditionally, biomanufacturing has depended on offline sampling, where materials are removed and sent to the lab for quality testing, a process that can take hours or even days. With PAT, those same insights can now be gathered in real time, enabling faster responses, greater reproducibility, and reduced batch variability.

Together, these approaches are changing not just how data are collected, but how manufacturing decisions are made, turning process analytics into a central pillar of modern bioproduction.

A View On Spray-Drying mRNA-based Products

Delivering mNRA Therapies: A Bullseye for Asthma and Future Pandemics In this episode, we speak with Carsten Rudolph, CEO and co-founder of Ethris, about a novel spray-dried mRNA therapy designed to restore immune balance in asthma patients and prepare for future pandemics.

This episode of A View On takes us deep into the lungs, where science, engineering, and medicine converge. Our guest, Carsten Rudolph, CEO and co-founder of Ethris, explains how his team is developing inhalable mRNA-based therapies for chronic respiratory conditions like asthma, rare diseases such as primary ciliary dyskinesia, and even protection in the case of future COVID-19-like pandemics.

Unlike vaccines, which target specific viruses, this approach focuses on strengthening the body’s innate immune response. Ethris’ lead candidate delivers instructions to lung cells to produce a protein that helps the respiratory tract fight off infections. In asthma patients, this immune response is often weakened, so restoring it could help prevent attacks. And since the effect is virus-agnostic, the same therapy could also be used preventively in vulnerable groups during pandemic outbreaks, offering protection before a tailored vaccine is available.

It’s a powerful example of how mRNA therapies could move out of the lab and into real-world use, improving chronic care while helping the world prepare for what comes next.

Unlocking Microbial Manufacturing: Innovation Across the Pipeline

For more than 40 years, microbial fermentation has been the workhorse of biologic manufacturing. From the first recombinant insulin to today’s increasingly complex therapeutic formats, the technology has consistently adapted to meet the needs of patients, developers, and regulators.

Karlheinz Flicker, Director of Microbial R&D, offers a strategic perspective on how microbial systems like E. coli and Pichia pastoris support emerging non-Fc biologics such as nanobodies and cytokines. Later, Joan Cortada, Associate Principal Scientist, walks us through a promising innovation in protein refolding that uses high pressure to reduce environmental impact and improve yields.

The episode underscores how upstream and downstream process innovation, from strain engineering to greener purification steps, can help make biologics more scalable, flexible, and sustainable.

A Swallow Instead of a Jab? A Capsule That Delivers Like an Injection

In this episode, we’re joined by Karsten Lindhardt, Founder and CEO of Biograil, to explore how a spring-loaded oral capsule could revolutionize drug delivery—offering patients a needle-free alternative with the same therapeutic impact as subcutaneous injections.

From insulin to monoclonal antibodies, biologic drugs are typically delivered through injections—often multiple times a week. For many patients, this isn’t just painful; it disrupts daily life and can be a major barrier to long-term treatment compliance. Imagine a world where those same treatments could be taken as a pill—no injections, no anxiety, no need for clinical visits.

That’s the vision behind Biograil’s BIONDD™ platform: a capsule that carries a mechanical device inside. Once swallowed, the capsule settles in the stomach, where it activates a spring-loaded insertion element like a bee’s stinger that delivers the active drug directly into the stomach lining. The result? Bioavailability comparable to injections, but with all the ease of an oral dose.

Want to Know More?

Join us in this conversation hosted by Martina Ribar Hestericová to hear how BioGrail is reshaping the future of biologic drug delivery—making it more convenient, less invasive, and better suited to real-life patient needs. We discuss everything from pediatric applications and veterinary uses to sustainability and the engineering behind this remarkable technology.

Pain in the Gut: Next Generation Therapy for Acid Reflux in the Pipeline

In this episode, we are joined by Kjell Anderson, Chief Scientific Officer at Cinclus Pharma, to discuss a novel treatment for acid reflux.

Millions of people worldwide grapple with acid reflux, which may progress to gastroesophageal reflux disease (GERD). Chronic acid exposure in the esophagus can lead to discomfort, inflammation, and even erosions—tissue damage that can severely affect a patient’s quality of life. While lifestyle modifications and standard proton pump inhibitors (PPIs) offer relief for some, they are not always effective for moderate to severe forms of GERD, largely due to limited coverage over a 24-hour period.

In this episode we discuss a next-generation compound—linaprazan glurate—designed to address these unmet needs. By providing a longer and more controlled suppression of gastric acid than traditional PPIs, this competitive, reversible inhibitor holds promise for patients whose symptoms or erosions persist despite standard therapy. With a Phase 2 study completed and Phase 3 on the horizon, linaprazan glurate could mark a turning point for those in search of more consistent relief.

Want to Know More?

Join us in this conversation hosted by Martina Ribar Hestericová, for the full story about the science behind acid reflux, challenges in clinical development, and how a novel therapy like linaprazan glurate may reshape the future of GERD treatment.

Driving Innovation Through Collaboration: The Future of mRNA Therapies

In this episode, we are joined by three experts—Christoph Hein (Fraunhofer IPK), Bernhard Bobusch (FDX Fluid Dynamix), and Sönke Stocker (Lonza)—to explore how advanced fluidics, encapsulation techniques, and a truly collaborative approach are paving the way for potential solid-tumor vaccines now in preclinical trials.

When you think about mRNA-based vaccines, have you ever considered the complex route these microscopic instructions must travel to deliver their life-changing code? This journey, essential for the therapy’s success, lies at the core of pharmaceutical research—where the challenge is to maximize stability and “bioavailability” so that each dose effectively reaches its cellular target.

By enclosing mRNA within lipid nanoparticles (LNPs) using sophisticated mixing technologies, scientists can create the next generation of therapies—tailored to each patient’s needs. From prophylactic vaccines to personalized cancer treatments for solid tumors, these breakthroughs promise not only more effective but also safer medical solutions. In this episode, we spotlight FDmiX®, a groundbreaking mixer platform that enables the precise production of LNPs, driving forward the possibility of new, life-saving vaccines in the fight against cancer.

Curious to Know More?

Join us in this conversation hosted by Martina Ribar Hestericová, featuring Fraunhofer IPK’s Christoph Hein, FDX Fluid Dynamix’s Bernhard Bobusch, and Lonza’s Sönke Stocker as they unveil how FDmiX® and mRNA encapsulation could revolutionize the development of solid-tumor vaccines and other cutting-edge therapies.

KEY TERMS IN CONTEXT:

In the world of mRNA therapeutics, a mixer refers to specialized devices—like FDmiX®—that rapidly and uniformly combine mRNA and lipid solutions. By generating precise fluid flows, these mixers ensure the formation of consistently sized lipid nanoparticles. This consistency is crucial for achieving stable formulations that protect mRNA until it reaches its target cells.

Lipid nanoparticles (LNPs) are tiny, fat-based carriers engineered to encapsulate and shield mRNA from degradation. Once administered, LNPs help transport their therapeutic cargo across cell membranes, allowing the mRNA to enter cells and guide protein production. In this way, LNPs bridge the gap between laboratory-synthesized mRNA and its ability to function effectively inside the body.

In vitro transcription is an enzymatic process used to create mRNA molecules outside of living cells. By copying a portion of DNA, researchers can produce custom strands of mRNA to encode specific therapeutic proteins. Once purified, these mRNA molecules are encapsulated in LNPs to be delivered into the patient’s cells, where the proteins are then synthesized in vivo.

Microfluidics involves manipulating tiny volumes of liquid through microscale channels, enabling precise control of flow and mixing. In mRNA manufacturing, this technology is key to creating uniform lipid nanoparticles by blending mRNA and lipid solutions in a highly controlled manner. However, these laminar devices are limited in throughput. Even though microfluidics and fluidic mixers may sound similar, they are fundamentally different devices. Fluidic mixers are based on turbulent mixing by integrating specialized flow paths—such as the oscillating nozzle in the FDmiX®— mixing platforms are taken to the next level generating rapid, turbulence-based mixing, ensuring consistency and minimizing product loss across all production scales from small batches to large volumes without compromising quality.

Ionizable lipids are specially designed molecules that alter their charge based on the surrounding pH. In mRNA encapsulation, these lipids help form stable LNPs in the bloodstream while promoting the release of mRNA payloads once inside cells. Their pH-sensitive nature is essential for balancing stability, delivery efficiency, and minimizing potential side effects.