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Episode 3: A View On mRNA Encapsulation

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.

Episode 2: A View On Antibody-Based Therapies

Antibody-Based Therapies: Transforming Modern Medicine

In this episode, we are joined by Ronnie Wei, Head of Biologics Discovery and Development at ModeX Therapeutics, and Atul Mohindra, Head of R&D for Biologics at Lonza, to explore the development and manufacturing of monoclonal, bi-, and multi-specific antibodies and their transformative role in modern medicine.

Everyday life is filled with stories of medical breakthroughs—new cancer treatments, therapies for rare diseases, and vaccines that protect millions. At the heart of many of these advances are antibody-based therapies. These life-changing medicines leverage the natural defense systems of the body to target diseases with precision and effectiveness.

Discover how these therapies are made, the cutting-edge technologies behind them, and what the future holds for this rapidly evolving field. Whether you’ve benefited from antibody-based medicine yourself or are curious about the science behind these treatments, this episode will connect the dots between the lab and real life.

Episode 1: A View On Emerging Trends in Pharmaceutical Manufacturing, live from CPHI Milan

We are back! Discover the latest in pharmaceutical innovation from CPHI Milan with A View On! This episode explores advancements in bioconjugates, AI-driven drug development, targeted capsule delivery, and new solutions in cell and gene therapy that are transforming patient care. Tune in to hear from Lonza experts on the future of pharma and biotech.

Episode 11: A View On the History of Capsule Manufacturing

Tracing the Evolution and Future of Capsule Manufacturing  

In this episode, we are joined by Ljiljana Palangetic, Associate Director of Hard Capsules R&D, and Bram Baert, Senior Director of Regulatory Affairs from Lonza, to delve into the intricacies of capsule manufacturing and the evolution of drug delivery technologies. 

Your grandmother might have told you to “just swallow your medicine,” suggesting that you may have to endure something unpleasant but necessary. Today, however, this old saying might not ring true, as capsules have become ubiquitous in modern medicine. Favored by 44% of consumers, capsules simplify medication intake with their ease of swallowing and ability to mask unpleasant tastes. From ancient Egyptian leather pouches to modern high-tech production lines, capsules have undergone significant transformations, seamlessly integrating into our daily lives. Swallowing one’s medicine has never been so easy.  

Yet the role of capsules has expanded far beyond taste masking. Today, they are engineered to deliver drugs to specific parts of the intestine, dissolve at controlled rates, and even contain multiple medications in one unit. This adaptability not only improves patient compliance but also caters to a myriad of medical needs. As we look toward the future, the potential for capsules in drug delivery is boundless, driven by continuous innovation and a deep understanding of materials science. 

As mentioned in the podcast, if you haven’t already listened to episode 9 of this season, you can find out more about targeted drug delivery using capsules here. 

 

Curious to Know More? 

Join us in this conversation hosted by Martina Hestericova with Lonza's Ljiljana Palangetic and Bram Baert as they unveil the advancements in capsule manufacturing technologies and their impact on modern drug delivery systems. 

 

KEY TERMS IN CONTEXT: 

Regulatory Affairs are crucial for ensuring that all pharmaceutical products, including capsules, adhere to legal and regulatory standards. Professionals in regulatory affairs navigate the complex landscape of pharmaceutical manufacturing, particularly focusing on consumer and patient safety, by collaborating with health authorities to establish and update regulations that ensure the safety and efficacy of capsules. 

Two-piece Capsules consist of a cap and a body that fit together, making them a versatile choice for different types of medication delivery. The design innovations of two-piece capsules have evolved significantly since their inception in the mid-19th century. They accommodate a multitude of materials such as powders or granules and playing a crucial role in modern automated manufacturing processes. 

Designed to pass through the stomach intact and dissolve in the intestines, enteric capsules are crucial for drugs that can be deactivated by stomach acid or may cause irritation to the stomach lining. This technology ensures that medication is released in the part of the gastrointestinal tract where its absorption is optimized, thereby enhancing both the drug's effectiveness and patient comfort. 

The use of polymer solutions is integral to forming the shells of capsules, particularly in technologies where a capsule is dipped into the solution, allowing the polymer to dry and harden. The choice of polymer affects the capsule's dissolution rate and stability, which is critical for ensuring that the drug is released at the correct rate and location in the body. 

Made from thin membranes derived from the small intestines of sheep, SAPARIS capsules are an early form of specialized drug delivery technology. They were designed to allow for a slow dissolution rate, aiming to improve the timing of drug release within the body. This technology showcases the evolution of capsule materials from organic origins to today's synthetic and semi-synthetic materials used in capsule manufacturing. 

Episode 10: Drug Bioavailability Enhancement

Simulating the Journey of Oral Medications: A Leap Towards Personalized Medicine 

In this episode, we are joined by Deanna Mudie, a senior principal engineer at Lonza, and John DiBella, president of PBPK & Cheminformatics at Simulations Plus, to discuss new techniques in enhancing the bioavailability of drugs. 

When you swallow a pill, have you ever pondered the intricate journey it undertakes to deliver its therapeutic effect? This voyage, crucial for the drug's effectiveness, is at the heart of pharmaceutical R&D's quest to enhance bioavailability - the proportion of the drug that enters circulation and reaches the target area. 

By simulating how drugs interact with the body, scientists can optimize therapeutic outcomes by tailoring medications to the needs of individual patients. This approach promises a future where drugs are not only more effective but also safer, with reduced side effects. Listen as we delve into the cutting-edge world of Physiologically Based Pharmacokinetic (PBPK) modeling. These computer models integrate factors like gastrointestinal physiology and population characteristics, shedding light on how drugs behave in various body systems without the need for extensive patient testing.  

Curious to Know More? 

Join us in this conversation hosted by Martina Hestericová with Lonza's Deanna Mudie and Simulations Plus's John DiBella as they unveil the potential of PBPK modeling to revolutionize drug development and personalized medicine.  

 

KEY TERMS IN CONTEXT: 

In the context of pharmaceuticals, drug bioavailability refers to the proportion of a drug that enters the circulation when introduced into the body and is thereby able to have an active effect. It's a critical factor in determining the drug's effectiveness, as it measures how much of a drug in a dosage form (like a tablet or injection) becomes available at the target site of action. 

PBPK modeling is a sophisticated computational modeling technique used to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs within animals and humans. This approach aids in understanding a drug's bioavailability and supports the design of more effective and safer drug therapies. 

Gastrointestinal Physiology refers to the study of the functions and processes of the digestive system or gastrointestinal (GI) tract. In the context of PBPK modeling, understanding gastrointestinal physiology is crucial for predicting how a drug is absorbed into the body, especially for orally administered medications. It includes factors like stomach acid levels, GI transit time, and the surface area available for absorption. 

"In silico" refers to the use of computer simulations or digital analyses to conduct experiments or procedures virtually rather than in a laboratory or real-world setting. In silico tools in drug development include software and algorithms used for modeling and simulation, such as PBPK models, which allow researchers to predict how drugs interact with animals and humans, aiding in drug design, testing, and the customization of therapies for personalized medicine. 

Episode 9: Capsules for Targeted Therapy Delivery

Capsules for Targeted Therapy: A Game-Changer in Modern Medicine 

In this episode we are joined by Vincent Jannin, Lonza's R&D Director, to explore Enprotect, the Award-Nominated Capsule Technology. 

Imagine starting your day with a simple capsule that goes beyond simply dissolving in your stomach to reach the place in your body where it is needed most before releasing its medicine. That’s just what Lonza’s Enprotect enteric capsules do. They are designed to release medication directly into the small intestine, which represents a significant leap in pharmaceutical delivery. They improve patient compliance without increasing production costs and offer targeted delivery for specific therapies such as live biotherapeutic products. This targeted approach is crucial for treatments that require local delivery, for example for Crohn's disease, exocrine pancreatic insufficiency, or Clostridium difficile infection. 

 

In this episode we hear from Vincent Jannin about how advances in polymer science have ushered in this new era of capsules capable of targeted drug delivery. This marvel of modern medicine combines the fields of chemistry, nanoscience, biology, and physics. The creation of a bilayer capsule—comprised of a structural layer for shape and a functional layer for targeted release—both required the development of new technologies and could itself serve as an enabling technology for future therapies. 

 

Vincent Jannin and his team have published several peer-reviewed studies in open access scientific journals, which were mentioned in the podcast: 

• In Vivo Evaluation of a Gastro-Resistant Enprotect Capsule under Postprandial Conditions (https://www.mdpi.com/1999-4923/15/11/2576) 
• In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule (https://www.mdpi.com/1999-4923/14/10/1999) 
• In vitro evaluation of the gastrointestinal delivery of acid-sensitive pancrelipase in a next generation enteric capsule using an exocrine pancreatic insufficiency disease model (https://www.sciencedirect.com/science/article/pii/S0378517322009966) 

Curious to Know More? 

Join us this episode as we explore the journey from a simple capsule to a sophisticated drug delivery system and how this advancement reflects a remarkable fusion of science and innovation. Discover how the Enprotect technology not only offers hope for more effective treatments but also exemplifies the relentless pursuit of medical advancement for the benefit of patients everywhere.  

 

KEY TERMS IN CONTEXT: 

An enteric capsule is a type of capsule specifically designed to bypass the acidic environment of the stomach and release its contents into the small intestine. The term 'enteric' relates to the small intestine. These capsules are formulated to remain intact in the stomach and dissolve only when they reach the more neutral pH levels of the intestine, ensuring targeted drug delivery. 

Enteric polymers are materials used in the construction of enteric capsules. They are chosen for their ability to withstand acidic conditions (like those in the stomach) and dissolve at higher pH levels like those found in the small intestine. HPMC Acetate Succinate is an example of an enteric polymer used for the outer layer of the capsule to ensure the treatment’s proper dissolution and release in the intestine. 

Live Biotherapeutics (LBPs) refer to live microorganisms used for therapeutic purposes. They are designed to interact with the human microbiome, particularly in the small intestine, and are sensitive to stomach environments. The protection LBPs need before their release in the desired intestinal location is facilitated by specialized capsules. 

Fecal Material Transfer refers to a medical treatment involving the transfer of fecal matter from a healthy donor to a patient, often used for conditions like Clostridium difficile infections. The podcast highlighted the potential use of enteric capsules for the delivery of such treatments directly to the small intestine, thereby offering an alternative to more invasive procedures. 

Episode 8: A View On Particle Identification

Embark on a microscopic journey into particle identification — the unsung hero of pharmaceutical safety — and uncover how this vital process shields us from unseen threats in every single medication we take.

Episode 7: Mid-season wrap-up

Season three so far, we’ve covered a lot!  

In this summary episode, A View On host Martina Hestericova shares a secret and goes over a selection of the best ideas from season three so far.  

 

The production team for A View On has managed to keep things moving along smoothly, so you most likely didn’t even notice that Martina was away for four months. She’s back! Listen in as Martina navigates us through a curated selection of the finest moments from the season: from cell culture to highly potent molecules, from inhalants to gene therapies, we’ve covered a lot this season.  

Check out this summary episode and stay tuned for future topics such as antibody based therapies, health ingredients, and even forensic science. 

Episode 6: A View On CAR-T Therapies

CAR-T Cell Therapy: Re-engineering the Immune System in the Fight Against Cancer 

In this episode, Tamara Laskowski, Senior Director of Clinical Development in Personalized Medicine at Lonza, and Aya Jakobovits, from Adicet Bio, discuss the therapeutic potential of CAR-T cell therapy.  

CAR-T cell therapy has generated immense enthusiasm within the oncology community since its first FDA approval in 2017. Currently, there are six commercially approved CAR-T cell-based therapies, with more on the horizon. These therapies have exhibited remarkable efficacy, particularly for patients who have exhausted standard treatment options. Industry experts Tamara Laskowski and Aya Jakobovits attest to the astounding outcomes witnessed in patients, some of whom have remained in remission for a decade after having received a CAR-T infusion. 

CAR-T cells are modified white blood cells that are introduced into a patient’s body. These remarkable cells are meticulously engineered to possess synthetic receptors, known as CARs, which enable them to first identify then eradicate malignant cells with precision. By targeting cancer cells that exhibit a specific target antigen, CAR T-cells have the extraordinary ability to seek out and eliminate harmful cells, offering new hope in the battle against this devastating disease. 

Curious to Know More? 

Join us on this podcast episode as we explore the therapeutic potential of CAR-T cells, their path to clinical trials, and their role in providing astonishing outcomes for patients with limited treatment options.  

 

KEY TERMS IN CONTEXT: 

A Chimeric antigen receptor (CAR) is a synthetic receptor engineered to be expressed on the surface of immune cells, particularly T cells, allowing them to recognize and bind to specific molecules or antigens present on cancer cells, triggering their destruction. CARs play a crucial role in CAR-T cell therapy by redirecting the immune cells to target and eliminate cancer cells with precision. 

CAR-T cell therapy is a revolutionary form of immunotherapy that involves engineering T cells to express CARs on their surface. These modified CAR-T cells are then infused into the patient, where they can recognize and target cancer cells, leading to potent and often long-lasting success with remission. 

Personalized medicine tailors medical treatments to individual patients based on their unique characteristics. In the context of CAR-T cell therapy, it involves genetically modifying a patient's own immune cells for customized and targeted cancer treatment. 

Autologous therapy is a CAR-T cell therapy approach that uses the patient's own T cells for manufacturing, whereas allogeneic therapy utilizes donor T cells as a cell source, offering potential advantages in terms of scalability and accessibility. 

Episode 5: A View On Highly-Potent APIs

Lonza experts Selene Araya and Charles Johnson discuss the manufacturing process, trends, and future of highly potent compounds (HPAPIs). They highlight Lonza's facilities and expertise in producing HPAPIs across various technologies and scales, ensuring advanced containment and addressing bioavailability challenges.