Our podcast series

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.”