Discoveries in technology, medicine, and nutrition are emerging with accelerating speed and improving our health and quality of life. Brought to you by Lonza, “A View On” podcast is a series of short conversations with industry leaders. Join us to discuss new trends that are impacting scientific research, drug discovery and business.

The series of monthly conversations with pharma, biotech and nutrition leaders from across industry and academia covers a wide range of topics from 3D bioprinting to therapeutic cannabinoids. In under ten minutes, each podcast takes the audience on a rapid but deep dive into an exciting development that promises to profoundly change or even revolutionize healthcare.


EPISODE 5: Therapy administration and its safety

From Gene to Vial to Patient: Lonza Experts Run Biotech Products Through a Gauntlet of Real-world Simulations Before Release

Hanns-Christian Mahler, head of Lonza Drug Products Services, and Ahmed Besheer, head of formulation development 2, talk about how Lonza is leading the way in providing an essential service to clinical partners.

In the field of CDMO drug development, the new gold standard is end-to-end service, or bringing a pharmaceutical from gene to vial to patient. In 2016 Lonza established its Drug Product Services (DPS) to realize this supply chain model for its partners and clients. Since then the DPS has grown to a workforce of over 250 experienced experts focused on safety, efficacy and quality. They reduce complexity and improve regulatory compliance for Lonza’s clinical partners. To ensure that Lonza’s pharmaceuticals perform as expected in real-world situations, the DPS team simulates the entire administration process until certain the patient will receive the correct dose of the highest quality. Lonza works with clients around the world, making this service indispensable to international partners and colleagues in clinical practice, since clinical circumstances and regulations can vary greatly from country to country. The DPS’s results also contribute to the basic science that informs drug creation and delivery, offering the opportunity for Lonza researchers to publish and share their discoveries with the larger scientific community.

Curious to Know More?
Listen to the conversation with Lonza researchers at Drug Product Services in this special, in-house episode of the podcast "A View On."


KEY TERMS:

Administration set: The set of tools and devices that allow for a clinical practitioner to administer a drug to a patient, for example via an intravenous IV setup. This usually includes the vial, the syringe to inject the drug into the IV bag, the bag itself along with the IV line, in-line filter and the cannula.

Administration process: The process by which clinicians employ the administration set to deliver the drug. Lonza’s DPS makes sure the interaction with the various materials and even possible human error do not adversely impact the product quality or interfere with dosing, e.g. due to drug adsorption.

In-use stability: The stability of the product during handling and administration considering its interaction with all the materials and forces needed to administer the product, such as the dilution in the delivery medium, potential adsorption to surfaces, hold times and administration process and environmental conditions like temperature and light. The keystone of DPS research and service is to ensure in-use stability for its clinical partners.

  • EPISODE 4: Cannabinoid-based medicines

    Not Your Parent's Weed: A Synthetic Cannabinoid Derivative Reaches Clinical Trials for Autoimmune and Fibrotic Diseases

    Dr. Alain Rolland, Chief Operating Officer & Executive Vice President of Emerald Health Pharmaceuticals, talks to Lonza about using novel synthetic drug candidates derived from cannabinoids for unmet medical needs.

    Cannabinoids are emerging as a serious treatment option for autoimmune and other immune-related diseases thanks to their modifications as synthetic derivatives. Emerald Health Pharmaceuticals (EHP) has widened the potential application of cannabinoids by designing cannabidiol (CBD) and cannabigerol (CBG) derivatives that have a greater effect on the endocannabinoid system and can even interact with receptors and pathways from other biosystems to treat autoimmune and fibrotic diseases. Advances by EHP and others are contributing to the larger acceptance of those novel molecules by the medical community and regulatory authorities. These are exciting times for cannabinoid researchers at EHP and their investors, given that the company has begun enrollment and dosed its first patients with diffuse cutaneous systemic sclerosis (dcSSc) in its Phase 2a clinical study of EHP-101, EHP's oral formulation of a patented new chemical entity (NCE) derived from CBD, and preparations for the initiation of a Phase 2 study in multiple sclerosis are planned for later this year. In addition, EHP-102, an oral formulation of a patented NCE derived from CBG, is in preclinical development for the treatment of Parkinson's and Huntington's diseases.

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


  • 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."


    KEY TERMS:

    Cellular medicine: The use of cells already found in the human body, frequently modified and enhanced, to treat diseases.

    Mesenchymal lineage cells: Cells whose function is to sense tissue inflammation through specific receptors for inflammatory cytokines and then secrete anti-inflammatory factors. They are present in all vascularized tissue and act as regulators that enable normal immune response in all organs. To learn more, visit: www.mesoblast.com/science/mesenchymal-lineage-cells.

    Immune cascade: When the body’s complementary immune system produces additional proteins, such as cytokines, to enhance the ability of antibodies to defend against microbes and damaged cells.

    Cytokines: These extremely small proteins, important in cell signaling, modulate immune responses. Mesoblast’s mesenchymal lineage cells interact with cytokines to modulate the inflammatory response of the immune system.

    Cytokine storm: This is when the body quickly releases too many cytokines into the blood, creating an exaggerated immune system inflammatory response that can be harmful and even deadly.

    Multimodal immune activation: When the body activates multiple immune responses to attack a virus or foreign body, potentially leading to dangerous inflammation of tissues in vital organs. The advantage of Mesoblast’s technology is that, unlike small molecules and monoclonal antibodies, their cellular medicines can simultaneously regulate several of these responses.

  • 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."


    KEY TERMS:

    Acidity of cancer cells: Current research shows that cancer cells exhibit a type of cell metabolism known as aerobic glycolysis, a process that generates lactic acid and creates a more acidic environment in and around tumors.

    Cell-penetrating peptide: Peptides are strings of amino acids that can be utilized for drug delivery. They are wobbly in structure and ineffective at penetrating cells under normal pH levels but rigidify when reaching acidic environments and can then enter the targeted cell.

    Linkers: A chemical bond that allows for a drug to attach to its carrier and be delivered to a specific target. For Cybrexa, this bond connects the peptide to the cytotoxic molecule or DNA inhibitor for efficient targeting of cancer cells and tumors.

    Cytotoxic drugs: Cytotoxic drugs in cancer therapy, such as chemotherapy, are not only toxic to cancer cells but do damage to other healthy cells, creating unwanted side effects to treatment. New research is showing how, when combined with cell-penetrating peptides, cytotoxic molecule delivery can be limited to the acidic environments of cancer cells, thereby avoiding off-target toxicity and bystander killings.

    DNA repair inhibitors: A relatively recent form of cancer treatment that oncologists often use in conjunction with chemotherapy. Inhibiting the repair mechanisms of cancer cells effectively turns the table on the tumor, the cancerous cells of which have hijacked the healthy DNA of a patient and use the cells natural repairing properties to become resistant to chemotherapy. By employing DNA repair inhibitors targeted specifically to cancer cells, researchers hope to increase the effectiveness of chemotherapy and reduce its side effects.

    Dose-limiting toxicity: When the side effects of a drug or other cancer treatment prohibit a dose increase that would otherwise be beneficial to the cancer therapy. By removing this boundary, therapies could be much more efficient in destroying cancerous cells in the body.


  • 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.”

    KEY TERMS:

    Desktop 3D bioprinting: 3D bioprinting, a process similar to other additive manufacturing techniques, uses bioinks and biomaterials to create biomedical parts for research like skin tissue and organoids such as corneas. These printers have traditionally been voluminous, complicated, and costly. Allevi’s desktop 3D bioprinters are not only smaller, they are easy to use and significantly less expensive than larger models.

    Bio-extrusion: A standard 3D printer at home or in a maker lab makes an object by adding material layer by layer. In bio-extrusion, bioinks are extruded from the nozzles and printed onto a biomaterial matrix.

    Bioink: A material composed of living cells and biopolymer gels that, once extruded by the printer, can be organised into tissues, organs, and organoids.

    Matrigel™: The trade name for the substrate used for culturing cells, essential in the bioprinting process as it is often the surface onto which the bioink is printed.

    Angiogenesis: From ancient Greek, literally the creation (genesis) of vessels (angio). In modern biology, the term refers to the formation of new blood vessels within a tissue. In bioprinting, the presence of angiogenesis means that the printed tissue is behaving and growing in a way that is akin to living tissue and is essential to the success of creating functional printed tissues and organs.

    Vascularization: Also related to the creation of blood vessels but, in contrast to angiogenesis, successful vascularization of a printed tissue is when an existing, printed structure of blood vessels is adopted by the tissue to delivering blood throughout the structure.

    Innervation: The process by which a tissue is supplied with nerves. In 3D bioprinting, supplying a printed tissue with nerves is the latest frontier of the technology as supplying tissue not only with blood but also nerves could possibly accelerate restoration of muscle function in vivo and create more complex tissue models for research on neurological diseases.

    For the above-mentioned article on angiogenesis and vascularization as well as the latest on bioprinting research, you can read more on the Allevi Blog.