EPISODE 11: A View On 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.

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.

EPISODE 9: 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
• In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule
• In vitro evaluation of the gastrointestinal delivery of acid-sensitive pancrelipase in a next generation enteric capsule using an exocrine pancreatic insufficiency disease model

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.

EPISODE 8: Particle Identification

Particle Identification, CSI Edition: Unveiling Invisible Threats in Pharmaceutical Manufacturing

In this episode we are joined by Pascal Chalus, Lonza's Associate Director of Particle Identification, to uncover the intricacies of ensuring drug products are free from both visible and subvisible particles.

Imagine a simple injection – a vaccine, an IV fluid, or an antibiotic. Its clarity is not just aesthetic; it's a testament to safety and efficacy. But lurking beneath this clear surface could be subvisible particles, invisible threats that pharmaceutical manufacturers work tirelessly to eliminate. These particles, although unseen, can reduce the effectiveness of a medication, trigger unwanted immune responses, or even cause dangerous blockages in the bloodstream.

How do we combat what we cannot see? This question leads us into an insightful discussion with Pascal Chalus, who draws intriguing parallels between pharmaceutical particle identification and the forensic science popularized by the TV series "CSI." Just as forensic experts identify unknown substances to solve crimes, scientists like Pascal identify and analyze particles in medications, tracing their origins to ensure patient safety.

This field impacts everyone who has ever received an injection, taken a tablet, or swallowed a capsule – essentially, every one of us. Innovations in this field hold the promise of raising the bar for drug safety standards and therapeutic efficacy.

Curious to Know More?

Join us in this intriguing episode as we explore the "good, the bad, and the ugly" of particles in pharma manufacturing—including finding a bug leg and tracing down its origins using DNA testing. Discover the meticulous process that keeps medications safe and the continuous advancements in the field of particle identification.

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: 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 the 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.

EPISODE 5: Highly Potent Compounds

Exploring Manufacturing and Market Trends in Highly Potent Compounds

In this episode, two Lonza experts, Managing Toxicologist Selene Araya and Charles Johnson, the Senior Director of Small Molecule Commercial Development, delve into the manufacturing process, trends, and future of highly potent compounds.

In the world of pharmaceuticals, some molecules possess an extraordinary level of potency. Known as highly potent compounds or HPAPIs, these substances have the remarkable ability to elicit a biological response in our bodies even at incredibly low doses—and they may even be the future of sustainable pharmaceuticals. Their potency enables targeted treatment of specific cell populations and often offers cost advantages in manufacturing. However, the production of highly potent compounds can create dangerous reactions and therefore comes with inherent risks for scientists and manufacturing personnel.

In this wide-ranging conversation about these powerful molecules, two in-house experts explore Lonza’s facilities and proficiency for the production of highly potent compounds, as well as the advantages of HPAPIs in different therapies. With Lonza’s extensive operating range, new safety challenges come up at each phase, whether it be small-scale lab operations or large-scale multi-ton batch manufacturing. Systematic approaches to protective measures ensure the safety of the staff, making sure to anticipate risks well in advance, and only relying on protective equipment as a last resort.

Curious to Know More?

Join us on this podcast episode as we explore the power and potential of highly potent compounds, delve into the challenges faced in their manufacturing, and envision a future where these compounds shape the landscape of sustainable pharmaceuticals.

EPISODE 4: Injectable Delivery Devices

The Future of Injectable Medical Devices and Their Impact on Patient Care and the Environment

In this episode, Ian Thomson, the Vice President of Business Development at Ypsomed, and Roman Matthäs, Lonza’s Associate Director of Pharmaceutical Services, discuss the market trends in injectable delivery devices, how these devices are manufactured, and their future in contributing to sustainable pharma.

For decades, patients have been using self-administration devices to deliver medications through subcutaneous injections, with the insulin pen injector as perhaps the most well-known of these devices. Recent developments in drug delivery and device technology are significantly expanding the market. To fully leverage this opportunity for the benefit of both patients and the industry, manufacturers are now embracing a comprehensive product development strategy that integrates medical device development from the outset. This exciting convergence of newly available therapies and innovative at-home delivery systems promises to improve patient quality of life and health, with far-reaching social and environmental benefits.

When these delivery options are available, patients no longer need to visit hospitals or clinics for injections, which saves time and money while reducing the risk of infections. Injectable devices can be self-administered in the comfort of the patient's home. They also allow for precise dosing, which is particularly important for patients who require frequent treatment.

Curious to Know More?

Listen to this episode of A View On: Injectable Medical Devices to explore how self-administered medical devices are manufactured and get an inside look into the future market trends from industry experts Ian Thomson (Ypsomed) and Roman Matthäs (Lonza).

EPISODE 3: Manufacturing Cell and Gene Therapies

Scaling Up Cell and Gene Therapies: Automation Is the Next Step 

In this episode, we take a deep dive into manufacturing cell and gene therapies with Lonza expert Behnam Ahmadian Baghbaderani, executive director of Cell and Gene Therapy Process Development.

Cell and gene therapies have the potential to revolutionize the treatment of rare genetic diseases, cancer, and neurodegenerative disorders. These therapies involve extracting cells or genetic material from a patient or donor, altering them and then re-injecting them back into the patient to provide a highly personalized treatment. However, the manufacturing process for these therapies is complex and expensive. To increase the availability of these therapies, the industry is making strides in scaling up the manufacturing process to reduce costs.

According to Behnam Ahmadian Baghbaderani, executive director of Cell and Gene Therapy Process Development at Lonza, “It is important to incorporate innovative technologies and reduce the cost of goods and production in order to make these therapies widely accessible for a large number of patients.”

One essential way to achieve this is through automation: automated cell culture systems, including bioreactors, can be used to grow and expand cells in a controlled environment, which reduces the need for manual labor while increasing consistency and reproducibility. Simply put, scaling up the manufacturing process using automation makes these therapies more widely accessible to the large number of patients who need them.

Curious to Know More?

Listen to this episode of A View On Cell and Gene Therapies to explore how cell and gene therapies are manufactured. Get an inside look into the next steps for the industry from Lonza expert Behnam Ahmadian Baghbaderani.

EPISODE 2: Manufacturing Inhaled Drug Products

What If the Jab Were a Puff? A Look at Drug Delivery to the Lungs

In this episode we explore the advantages of using inhalers for drug delivery with Lonza experts Kim Shepard and Matt Ferguson.

In late 2022, China introduced the world’s first Covid-19 vaccine to be inhaled into the lungs. The Chinese scientists who developed the vaccine tout its ability to directly stimu-late the immune system’s first line of defence – the lungs’ mucous membrane. However, vaccines are just the tip of the inhaler iceberg. While we all are familiar with metered-dose inhalers, as well as nebulizers, for asthma, a whole range of therapeutic options for many diseases are becoming available through the technology known as dry-powder in-halers, or DPI.

While the first commercially available DPIs appeared in the seventies, recent advances have opened the door to treatments for diabetes and even cancer. As with the Covid-19 vaccine, direct delivery to the lungs can be more efficient, but it also has the advantage of lowering toxicity by bypassing the liver altogether. Still, getting the correct amount of the molecule to the right part of the lung without unwanted immune responses is tricky business. Recently developed manufacturing techniques and new types of molecules make drug inhalers a continually evolving field full of potential advantages for patients.

Curious to Know More?

Listen to this episode of A View On, Manufacturing Inhaled Drug Products to learn more about what it takes to develop effective treatments with insights from Lonza’s Associate Director, R&D, Kim Shepard and Matt Ferguson, Lonza’s Head of Respiratory Drug De-livery.

EPISODE 1: Cell Culture Media

We are back! And in the first episode of our new season, we explore growing cells for therapeutic purposes with Lonza specialists Alexis Bossie, Director of Media R&D, and Tariq Haq, Senior Director of Global Media Marketing.

Lab-grown meat is having a moment—the FDA just declared one company’s culti-vated chicken safe to eat, and another type of lab poultry was just served for dinner to delegates at this year’s COP27 climate conference in Egypt. Whether this piques your pallet’s curiosity or turns your stomach, one thing is clear: growing meat in a lab for human consumption will take massive amounts of cell media.

What is cell culture media? It is the medium in which cells grow in a lab, serving as both the cell’s food and its shelter. The medium can take various forms, depending on which cell type is being grown and for what specific purpose. It is a careful re-cipe that balances the complex needs of cells in nutrients, energy, pH balance and saline percentage. Like our bodies, cell culture media is mostly water. However, crafting the right media is no simple matter: choosing the correct formula can make all the difference for the cell growth outcome, whether trying to stimulate virus pro-duction or make the tastiest animal-free cultivated cordon bleu on the planet.

Curious to Know More?

Listen to this episode of A View On, On to learn more about what it takes to grow cells in a lab. As a bonus for our listen-ers, at the end of the discussion, Alexis Bossie shares insights into the possibilities and obstacles of growing meat in the lab.

EPISODE 10: Artificial Intelligence and Life Sciences: The Dawning of a Digital Revolution in Pharma Manufacturing

Dr. Loubna Bouarfa, CEO of OKRA.ai, and Stephan Rosenberger, Lonza's Head of Digital Transformation, discuss how AI is currently transforming the pharma industry.

Machine learning is an essential subset of the vast field of Artificial Intelligence, in which computer programs aim to mimic human intelligence. Machine learning is at work in many of the algorithms that impact our daily lives, from suggesting new songs we might like to targeting ads. These algorithms learn from large data sets similarly to how a child learns during the early stages of development. As the algorithm matures from child to teenager to adult, it refines its own functioning by learning from its errors and through help from humans, much like we do.

This powerful way of programming is making tsunamis across nearly all industries. It notably transforms the pharmaceutical world from drug discovery to production and even sales. Whether it is creating AI brains for companies to build digital workers to help their human employees or streamlining the factory with ultra-reliable predictive maintenance, the machine learning and artificial intelligence revolution is well underway.

Curious to Know More?

Listen to the conversation between A View On host Martina Hestericová and two world specialists about the present and future applications of AI and Machine Learning in the pharmaceutical industry.

EPISODE 9: Where There’s A Risk, There’s A Way: De-risking Drug Development at the Earliest Stages

Lonza’s wide array of analytical tools and professional experience create a go-to solution for small biotechs looking to decrease risk in their drug development process.

A successful drug can easily take up to 15 years and cost over 2 billion US dollars to de-velop. Considering that nine out of ten drug candidates fail in clinical trials, companies are incentivized to reduce the risk of drug attrition at the earliest stages of development. Many of the drugs currently in the manufacturing process around the world are initially developed by small biotech companies—companies that often do not have the tools and experience necessary to assess the risks of developing their therapeutic drug can-didates properly. This is where Lonza’s Early Development Services steps in, headed by today’s guest Raymond Donninger.

To start the de-risking process, Donninger and his team employ the latest computer modeling tools to predict how the molecule will react with a human body. And while these in silico tools are very powerful, several other steps are needed to fully assess risk potential, including novel cell-based assays and a full economic viability appraisal. The de-risking process is highly technical and relies on years of research experience since no novel algorithm or new in vivo testing technique—regardless of its power—can fully replace the analytical acuity of the human brain combined with decades of market know-how.

Curious to Know More?

We previously addressed the importance of immunogenicity in decreasing risk in drug production in Episode 5. To take an even deeper dive into the whole process, listen to the conversation between Martina Hestericová and Raymond Donninger, the Senior Di-rector of Commercial Development for Lonza’s Early Development Services.

EPISODE 8: Capsule Manufacturing: It’s Not Only What’s Inside That Counts

The recent EU ban on Titanium Dioxide and changing customer habits are shaking up capsule production.

Over the past few years, the coloring and manufacturing of pill capsules have undergone significant changes due to new EU regulations and customer demand for natural ingredients. And while originally invented to mask and protect the contents inside a capsule, research suggests that the color of a tablet or pill can affect how patients feel about their medication.

Until recently, manufacturers have primarily used Titanium Dioxide (TiO2) to create white capsules due to its efficiency in protecting the active ingredients from UV rays. However, this year an EU-wide ban on TiO2 has forced the industry to move towards alternatives that work as well, or better, than TiO2. To add to the colorant shake-up, many people are actively avoiding unnatural ingredients in their food and nutritional supplements, which has created a new demand for plant-based capsule colorants. Anticipating these changes and solving the technological challenges in a timely manner are key to a successful long-term strategy for capsule manufacturing.

Curious to Know More?

Listen to the conversation between A View On host Martina Hestericová and Ljiljana Palangetic, Lonza’s Associate Director of Hard Capsules R&D, about the challenges and solutions in current capsule manufacturing.

EPISODE 7: Antibody-Drug Conjugates: Next Generation of Targeted Cancer Treatements

Iwan Bertholjotti and Lawrence Bonnafoux from Lonza give an insider look at how these promising treatments make it from development to commercialization.

Chemotherapy is the first-line treatment for most types of cancer. However, one of the major challenges with this approach is that it targets both cancer and healthy cells, with patients suffering severe side effects. A new class of therapies, called antibody-drug conjugates, or ADCs, can target tumors much more precisely by harnessing the power of antibodies. The antibody can bind specific types of tumor cells, delivering a fatal blow to the cancer cells while sparing healthy cells. These promising new drugs have seen a significant uptick in FDA approvals in recent years, pointing towards a trend that could transform the way many diseases are treated.

While numerous companies succeed in developing promising ADCs, manufacturing such complex and highly potent treatments presents unique challenges. The intricacy of scaling up the manufacturing of ADCs leads many companies to outsource their production, and Lonza currently fabricates the majority of ADC therapeutics in the world. For the companies that choose to work with Lonza, the collaboration simplifies the process and streamlines the supply chain. Decades of collective experience in fabricating ADCs means that the drugs make it from discovery to approval in less time, improving patients' lives through more effective, targeted treatments with fewer side effects.

Curious to Know More?

Listen to the conversation between A View On host Martina Hestericová and two of Lonza’s experts on ADC manufacturing—Lonza’s senior director of Commercial Development of bioconjugates, Iwan Betholjotti, and Lawrence Bonnafoux, Lonza’s Head of MSAT BioConjugates.

EPISODE 6: Manufacturing of Exosomes

Putting Manufacturing First: Codiak Moves Swiftly into Clinical Trials with Exosome-based Treatments

Sriram Sathyanarayanan, Codiak’s CSO, and Linda Bain, their CFO, share how the company moved into clinical trials in under 6 years.

Exosomes, extremely small vesicles shed by all cell types, promise to become a viable delivery system for treatments of many diseases. But until recently, manufacturing them at a commercially viable scale has been unfeasible. That is why in 2015 the company Codiak took a two-pronged approach to developing exosome-based treatments: prioritizing both the engineering and manufacturing tracks from the outset. A mere six years after the company was launched, this approach has proven effective, with two promising studies in the clinic for tumor treatments, while most other developers are still at the starting blocks.

The exosome field today holds the kind of promise that antibody and protein-based therapeutics did in the 1980s—the potential to improve both treatments and patient well-being is great. With a low risk of immunotoxicity, leveraging their natural abilities and engineering them to deliver targeted therapies could open new therapeutic pathways to previously undruggable targets. Yet as recently as only a couple of years ago, manufacturing exosomes was limited to small batches. Codiak has successfully increased production to thousand-liter batches, permitting clinical studies and greatly improving the prospective of widespread use. In collaboration with Lonza, Codiak is doubling down on their advantage with a recently established Center of Excellence for exosome manufacturing in Massachusetts.

To learn more about Codiak’s pipeline of therapeutic candidates with a potential to transform patients’ lives, visit: https://www.codiakbio.com/pipeline-programs/pipeline

Curious to Know More?

Listen to Martina Hestericová’s conversation with Sriram Sathyanarayanan and Linda Bain as they discuss the advantages of exosome treatments, how they are developed and why the company’s early manufacturing strategy is paying off.

EPISODE 5: Importance of Immunogenicity

De-risking Drug Development: Early Testing for Toxicity Saves Time and Resources

Yvette Stallwood, head of Lonza’s Early Development Services, talks about patient safety and other advantages of early testing for immunogenicity in the drug development pipeline.

In the high-stakes drug discovery game, from IND filings all the way up through the clinical trial phase, regulatory authorities are now expecting developers to have an immunogenicity risk strategy in place. “It really is essential that drug developers assess the immunogenicity risk as early as possible in the pipeline, as not only can it impact the functionality of the drug, but it can also be a significant safety risk for the patient,” explains Yvette Stallwood, whose work at Lonza’s Early Development Services (EDS) is helping small and large biotech companies reduce risk with a “Right First Time” approach when developing drug therapies.

Drug candidates often fail during clinical trials due to their toxicity to patients, which is evident, for example, in an immunogenic reaction—where the drug triggers an unwanted immune response known as immunotoxicity. This can result in the loss of years of work and funding. Stallwood and her team encourage their clients to begin with in-silico testing, where up to a thousand digital models of potential immunoresponses can be predicted. Once the digital models show a candidate to have a low risk of toxicity, the EDS team then moves to human donor cell assays—with the advantage of screening up to fifty different immunotypes. The ideal time to assess immunosafety and immunotoxicity is well before deciding on a molecule as a lead drug candidate. By understanding as much as possible about the potential product through early testing, biotech companies are better equipped to take the correct path to regulatory approval with a drug that is ultimately safer for patients.

Curious to Know More?

Listen to the conversation between A View On host Martina Hestericová and Lonza’s head of EDS Yvette Stallwood as they discuss de-risking the drug development process.

Host and Health: Tailoring Personalized Medicine Using The Unique Microbiome Fingerprint

Professor Eran Elinav from the Weizmann Institute of Science discusses how the interaction between the microbiome and its host is transforming personalized medicine.

I believe that in the next five to ten years, exploiting the potential of the microbiome will be central to personalized and precision medicine,” explains eran elinav. his research into this second genome in the human body at the weizmann institute of science in isreal is shedding light how these trillions of cells function and interact with their host. the individualized data from the unique microbiome fingerprint can be harnessed to tailor nutritional therapies to improve metabolic functions in the treatment of, for example, obesity and type 2 diabetes—with a wide range of further potential applications. and even small molecules found within the microbiome could themselves be developed into drugs. the future hope lies in the inherent therapeutic translatability of these insights from host-microbiome interaction research into treating the whole spectrum of metabolic

Curious to Know More?

Listen to the conversation between Lonza’s Martina Hestericová and Weizmann Institute of Science Professor and researcher Eran Elinav in this special episode of the "A View On" podcast.

Bridging Business and Biotechnology: Kodiak Sciences Is Increasing Treatment Efficacy for Retinal Diseases

Victor Perlroth, MD, the Chairman and CEO of Kodiak Sciences, discusses how the company’s ABC platform medicines are designed to treat the leading causes of blindness.

Age-related macular degeneration (AMD) is one of the leading causes of blindness in adults worldwide. This disease deteriorates the macula, a miraculous little spot on your retina that allows for precise vision in good light. Although several treatments exist for macular deterioration, they require frequent trips to the doctor’s office for uncomfortable but quick and routine injections directly into the eye. The required frequency of the treatments means that most patients miss appointments, leading to undertreatment of the disease and permanent vision loss. In a manufacturing collaboration with Lonza, Kodiak is designing novel antibody-biopolymer conjugate (or ABC) medicines with the same efficacy and safety with much longer durability, allowing patients to visit the doctor on a realistic schedule over the long term. By focusing on business implementation alongside formidable biotech R&D, Kodiak Sciences is on track to bring together the necessary clinical and manufacturing elements for an FDA filing in 2023.

Curious to Know More?

In this most recent episode of “A View On,” Lonza’s Martina Hestericová is joined by Victor Perlroth, MD, the co-founder and CEO of Kodiak Sciences, to talk about the recent developments in AMD treatment research.

Episode 2: Horseshoe crabs and recombinant factor C

Safe Jabs Thanks to Horseshoe Crabs: Making Sure Your Injection is Free of Endotoxins

Allen Burgenson, Lonza’s expert for all things testing, speaks to us about the dangers of endotoxin contamination and the future of non-animal testing for it.

“Before testing for endotoxins in the 1940s, a physician literally had to gauge the risk to your life because of something called injection fever,” explains Allen Burgenson. Luckily, we’ve come a long way since then. Thanks to advanced testing methods, one can rest assured today that any sort of injection or implant is completely free of dangerous endotoxins. Currently, the predominant mode is Limulus Amebocyte Lysate (LAL) testing, in which scientists harvest the bright blue blood of American Horseshoe Crabs and use the animal’s primitive immune system to look for clotting reactions that would indicate the presence of any endotoxins. The horseshoe crabs, Burgenson explains, survive the extraction unscathed and are safely returned to the waters in less than 24 hours. However, in a continual attempt to remove animals from the testing pipeline, Lonza’s recombinant factor C assay known as PyroGene could eventually replace LAL testing.

Curious to Know More?

In Episode 2 of the new season of the podcast A View On, host Martina Ribarhestericova speaks with Lonza expert Allen Burgenson to discuss his close bond with the American Horseshoe Crab and the history of testing for endotoxin contamination.

A Welcome Virus: Cracking the Viral Code for the Battle Against Cancer

Chairman and founder of PsiVac, Prof. Ghassan Alusi, and the chief operating officer, Imad Mardini, discuss how the company’s proprietary oncolytic virus platform offers new hope for cancer patients.

During a time when everyone actively fears viruses (especially THE virus) and their mutations, it is only cancer cells that have cause to worry about oncolytic viruses, and rightly so. These mutated viruses are administered directly into a tumor. Once inside, they crack open the tumor’s cells in a process known as lysing that provokes a strong response from the body’s immune system, which has, until then, ignored the cancerous cells. What’s more, the therapy’s attack doesn’t stop at a single tumor. The replicating and lysing viruses release previously hidden tumor-associated antigens (TAAs) that alert the immune system about cancer cells to attack all over the body. The body’s own immune system then goes on to destroy previously unrecognized tumors far removed from the initial injection point. The biotech company PsiVac advances this technology even further by creating a treatment platform that transforms the adenovirus, aka the common cold, into an especially powerful oncolytic virus. A precision modification in the virus’s DNA improves its efficiency against cancer cells while making it harmless to other cells, rendering the treatment at once more effective and safer for patients. “Now that the technologies of other forms of immunotherapy are gaining ground, and as cancer remains a major cause of mortality, we now understand there is a huge need for oncolytic viral therapy,” says Prof. Alusi, whose company has planned to start Phase 1 clinical trials later this year. Unlike other immunotherapies, such as patient-centric CAR T-cell therapy, oncolytic viruses can be made in relatively large quantities once their efficacy and safety have been proved.

Curious to Know More?
In the first episode of the new season of the podcast A View On, host Martina Ribar Hestericová discusses the current state of oncolytic viruses and their promising applications with Prof. Ghassan Alusi and Imad Mardini.

EPISODE 10: Phage Therapy

Devouring Bacteria: How Phage Therapy Is Shaping Antibacterial Treatments of the Future

In this episode we speak with the CEO of BiomX, Jonathan Solomon, about produc-ing and using phages to test and treat various diseases and conditions.

Until very recently, treating a condition such as acne with an army of microscopic bacteria-destroyers known as phages—bacterial viruses that target and kill specific bacteria—would have seemed highly unlikely. However new research linking acne to an imbalance in the skin’s microbiome has opened the door to innovative treatment approaches. That’s where the biotech company BiomX comes in. Uniting powerful computational science with the in-herent capacity of phages to destroy specific bacteria, BiomX creates natural and synthetic phage therapies for some of the most troublesome bacteria-related health issues: acne, atopic dermatitis, cystic fibrosis, inflammatory bowel disease (IBD) and even colorectal can-cer. For acne the company has developed a successful cocktail of three different phages to treat the condition, with phase 2 testing close on the horizon. BiomX’s developments in phage therapy promise to change the way we treat imbalances in our microbiome, with potential health benefits for large swaths of the population.

Curious to Know More?
To learn more about BiomX, listen to the conversation with Jonathan Solomon on this episode of A View On: Phage Therapy.

EPISODE 9: Streamlining Cell and Gene Therapy Manufacturing

Delivering Personalized Therapies: Streamlining the Supply Chain for a New Generation of Treatments

In this episode, we speak with Amy DuRoss, Co-Founder and Chief Executive Officer of Vineti, about the challenges facing "just-in-time" manufacturing and delivery of personalized therapies—and the solutions her digital startup provides.

According to Amy DuRoss, the COVID-19 vaccine distribution has exposed existing deficiencies in the entire pharmaceutical supply chain. This situation echoes, albeit on a far smaller scale, the distribution complexities of delivering cell and gene therapies (CGT). Unlike more traditional treatments, CGT requires the extraction of live cells from a patient or donor to then be delivered to a manufacturer and make it back to the patient in a timely manner. Her company Vineti "introduces a new level of fidelity, control, and transparency" into the personalized drug delivery process, streamlining CGT distribution through a novel digital orchestration platform. Based on an astute understanding of the behavior of care providers, specialized couriers and CGT manufacturers, her company has developed a software infrastructure that supports this exponentially complex delivery process. By facilitating Good Manufacturing Principles for all required stakeholders in the advanced therapy process, the Vineti platform ensures regulatory compliance and maintains both Chain of Identity and Chain of Custody from cell collection to manufacturer and back to the patient.

Curious to Know More?
Take a listen to this episode of A View On: Streamlining Cell and Gene Therapy Manufacturing to learn more about Vineti. At the end of the discussion, as a bonus for our listeners, Amy DuRoss offers insight into some of the difficulties encountered in the COVID vaccine rollout, and how it parallels the complexity of the supply chain for CGT.

Exosomes Know Where To Go: Using the Body's Own Cell-to-Cell Communication Network for Diagnostics and Drug Delivery

We speak with Uwe Gottschalk, the Chief Scientific Officer of Lonza, about how a better understanding of exosomes is leading to new treatments and diagnostic technologies.

According to Uwe Gottschalk, the exosome revolution is already in full march. As researchers begin to identify how these cell-generated, nano-sized delivery drones function in the human body, novel drug delivery prospects are emerging, including applications for cancer, neurodegenerative diseases and spinal cord injury recovery. Perhaps even more exciting is the role exosomes will play in diagnostic applications in the near future, wherein a liquid biopsy, based on a blood sample, would detect cancer or other diseases both more easily and in a more timely fashion than traditional biopsies. One of the many challenges is the ongoing task of defining the manufacturing protocols and processes for this new biotechnological paradigm. Even so, the field is abuzz with new discoveries, trials and general optimism about the potential of these microscopic extracellular delivery vehicles.

Curious to Know More?
Lonza's Chief Scientific Officer gives us his expert insight into exosome research and application in this special, in-house episode of the podcast "A View On."

EPISODE 7: Bacthera

Bugs as Drugs: Harnessing the Therapeutic Potential of the Microbiome

Lukas Schüpbach, the CEO of Bacthera, and Gemma Henderson, Bacthera’s Head of Project and Portfolio Management, speak to Lonza about creating pharmaceuticals from the human microbiome.

The human microbiome, comprised of trillions of bacteria, fungi, viruses, and archaea, is unique to each individual and develops over the course of lifetime, stabilizing once we reach adulthood. Despite the widespread understanding that this microbiome is a key component to our health, there are currently no commercially available live biotherapeutic products (LBPs). There is, however, an increasing amount of scientific evidence that using live biotherapeutic products to promote a vigorous microbiome can improve general physical health and positively impact quality of life by targeting diseases such as obesity, diabetes, inflammatory bowel syndrome and cancer. The biopharma company Bacthera is manufacturing and testing these difficult-to-produce anaerobic bacteria treatments that could improve metabolic functions and have anti-inflammatory effects. Alongside manufacturing, Bacthera is meeting the challenging delivery process to harness the therapeutic potential of the microbiome through easily administered, encapsulated pills.

Curious to Know More?
Listen to the conversation between Lonza and Bacthera in this episode of the podcast "A View On."

EPISODE 6: Gene editing

Pioneering Precision: Cellectis Develops Immunotherapies for Genetic Diseases and Disorders Through Cutting-edge Gene Editing

André Choulika, the Chairman and CEO of Cellectis, talks to Lonza about the company's clinical trials of their revolutionary gene editing technology.

Since the arrival of Crispr in 2009, gene editing has made its way into labs across the globe, and its groundbreaking importance was further acknowledged through the 2020 Nobel Prize in Chemistry. Gene editing corrects within the DNA exactly as one edits a text: cutting, copying, replacing and deleting. Taking up the mantle of gene editing for medical treatments, the biopharmaceutical company Cellectis focuses their 20 years of experience on developing cancer immunotherapies. Safety through precision is the ultimate priority for Cellectis. The gene-editing company turns to Crispr for research but has found TALEN to be more precise in therapeutic uses. First, the gene cutter is introduced into a healthy donor T cell to destroy its receptor. This makes it blind so that the T cell doesn't attack the patient's cells (also known as graft versus host disease), and only the CAR carries the information about which cells to attack. The TALEN then travels to the cell via the CAR-T cell and cleaves the gene where it needs to be corrected. Cellectis has several products in the clinical trial stage that are based on allogenic gene-edited CAR-T cells: U CAR-T 22 for acute lymphoblastic leukemia, U CAR-T 123 for acute myeloid leukemia, and U CAR-CS1 for multiple myeloma.

Curious to Know More?
Cellectis CEO André Choulika explains the technology of allogenic gene editing they invented in this episode of the podcast "A View On."

EPISODE 5: Therapy administration and its safety

EPISODE 4: Cannabinoid-based medicines

EPISODE 3: Mesenchymal stem cells for COVID-19 treatment

Off-the-shelf Cell Therapy Remestemcel-L Targeting the Lethal Complication of the COVID-19 Pandemic

Mesoblast CEO Dr. Silviu Itescu speaks to Lonza about the company’s advanced portfolio of anti-inflammatory allogeneic cellular medicines including remestemcel-L, which is currently being evaluated in a U.S. Phase 3 randomized controlled trial for acute respiratory distress syndrome (ARDS), the principal cause of mortality due to COVID-19 infection.

Most COVID-19-related deaths result from ARDS, an overactive immune response that creates overwhelming inflammation in lung tissue. As the world suffers in the grip of this pandemic, some hope comes from Mesoblast. They have dedicated the past 15 years to developing a portfolio of product candidates based on mesenchymal lineage cells to treat severe inflammatory diseases such as graft versus host disease, advanced heart failure, and chronic low back pain. Their strategy for treating inflammatory diseases uses cellular medicines instead of small molecules or monoclonal antibodies, thereby treating an out-of-control immune system on a systemic level by impacting multiple inflammatory pathways at the same time. This positions them well to provide much-needed treatment for those COVID-19 ARDS patients left with few – or no – options. The Phase 3 trial was informed by the positive results from an emergency compassionate use protocol in patients on mechanical ventilation with COVID-19 ARDS at Mt Sinai Hospital in New York where 75% (nine of 12) patients were discharged home compared to a mortality rate of around 80% recorded in New York over the same time period in patients with COVID-19 ARDS who were not treated with remestemcel-L. Interim analyses of the 300-patient trial are planned, and Mesoblast Chief Executive Dr. Silviu Itescu is eagerly awaiting results.

Curious to Know More?
Listen to the conversation between Lonza and Mesoblast Chief Executive Dr. Silviu Itescu in this episode of the podcast, "A View On."

New Arsenal in the Battle Against Cancer: Pharmaceutical Smart Bombs Promise Less Collateral Damage for Patients

Cybrexa Therapeutics CEO Per Hellsund and CSO Vishwas Paralkar talk to Lonza about how their enterprise is shaping the future of cancer treatment with cell-penetrating peptides.

One of the biggest obstacles to safely eliminating cancerous cells is that most therapies also negatively impact a patient's healthy organs and tissues, known as bystanders. This notorious problem has hindered effective treatment since the beginning of oncology and often has devastating effects on patients’ quality of life. One novel strategy pursued by Cybrexa Therapeutics is the design of treatments that specifically target solid tumors made of cancer cells by taking advantage of one of their universal biomarkers – acidity. The company has developed a platform that leverages the low pH environment inherent to cancer cell metabolism. By using cell-penetrating peptides bearing an anticancer cargo load, their platform brings the treatment directly inside tumors, leaving healthy cells alone and minimizing bystander killings. This smart anti-tumor technology promises to be applicable to a wide swath of patients and reduce side effects of cancer treatment

Curious to Know More?
Listen to the conversation between Lonza and Cybrexa Therapeutics researchers in this episode of the podcast "A View On."

From the International Space Station to Desktop Printers, 3D Bioprinting Is Revolutionizing Tissue Model Research

Allevi CEO Ricky Solorzano talks to Lonza about how his company is empowering scientists to print their own tissue models

Scientists have been printing cells for decades, but with the arrival of 3D bioprinters, getting printed tissue models to behave like living tissue has proved elusive. That is why angiogenesis and vascularization are two holy grails of 3D bioprinting. A recent article published by researchers at biotech company Allevi demonstrates breakthrough research in which a skin tissue model printed on one of their desktop models showed both processes simultaneously. The April 2020 publication in ACS Biomaterials, Science & Engineering illustrates just how fast bioprinting is moving, producing results that were unimaginable five years ago, facilitating the study of tissue models in basic science, disease modeling, and drug discovery. But Allevi is not stopping at Earth-bound breakthroughs. The US company has also secured funding for simultaneous bioprinting experiments on the International Space Station.

Curious to Know More?
Listen to the conversation between Lonza and Allevi CEO Ricky Solorzano about both the current state of bioprinting and its future applications in the first episode of the podcast “A View On.”