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The BioDisruptors Podcast – Making Biotech Make Sense 🧬
Biotech is evolving fast, but keeping up shouldn’t feel like reading a textbook. We break down dense white papers and complex science into clear, engaging discussions—so you stay informed without the headache.
Whether you're a biotech professional or just curious about the latest breakthroughs, we’ve got you covered. No fluff, no unnecessary jargon—just biotech made simple.
🔬 Follow us to stay ahead of the latest biotech innovations!
🎧 Listen now and turn biotech complexity into clarity.
Biotech is evolving fast, but keeping up shouldn’t feel like reading a textbook. We break down dense white papers and complex science into clear, engaging discussions—so you stay informed without the headache.
Whether you're a biotech professional or just curious about the latest breakthroughs, we’ve got you covered. No fluff, no unnecessary jargon—just biotech made simple.
🔬 Follow us to stay ahead of the latest biotech innovations!
🎧 Listen now and turn biotech complexity into clarity.
23Â Episodes
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Antibody–drug conjugates, or ADCs, are transforming cancer therapy by combining the precision of monoclonal antibodies with the potency of cytotoxic drugs. In this episode, we explore the science behind ADC design, including the choice of antibody backbones, linker technologies, and payload classes. We also look at lessons learned from early market withdrawals, the resurgence of re-engineered therapies, and how bystander effects shape clinical outcomes. With more than 15 approvals, ADCs represent one of the fastest-growing classes in oncology. Tune in to learn how scientific innovation and careful design choices are shaping the future of targeted cancer treatment.Featured Article: Antibody–Drug Conjugates (ADCs): Current and Future Biopharmaceuticals(https://doi.org/10.1186/s13045-025-01704-3)
The promise of 3D printing in healthcare is no longer science fiction. In this episode of BioDisruptors, we dive into how this technology is reshaping patient care with everything from tailor made implants and surgical models to living tissues created from patient cells. We explore the main printing methods used in medicine, the science of bio-inks, and the challenges of maintaining cell health during the printing process. Whether you are curious about the science or the future of medicine, this episode makes complex biotech breakthroughs easy to follow.Featured Article:Â Process, Material, and Regulatory Considerations for 3D Printed Medical Devices and Tissue Constructs(https://doi.org/10.1016/j.eng.2024.01.028)
In this episode, we explore the fascinating world of gene therapy vectors, the delivery systems that make genetic medicine possible. We look at how viral vectors such as lentiviruses, adenoviruses, and adeno-associated viruses each bring unique strengths, from powering CAR T cancer treatments to enabling cures for inherited blindness and spinal muscular atrophy. We also unpack the challenges, including risks of insertional mutagenesis, immune reactions, and cargo size limits that continue to drive scientific innovation. Finally, we turn to the fast growing field of non-viral vectors, including lipid nanoparticles and GalNAc conjugates, which are creating new opportunities for safer and more scalable therapies. Whether you are curious about the science or the future of medicine, this episode makes complex biotech breakthroughs easy to follow.Featured Article:Â Viral and Non-Viral Vectors in Gene Therapy: Current State and Clinical Perspectives(https://doi.org/10.1016/j.ebiom.2025.105834)
In this episode, we explore how membrane filtration safeguards biopharma products such as antibodies, mRNA vaccines, and viral vectors. We walk through the key steps from microfiltration and ultrafiltration to virus and sterilizing filtration, showing how each stage protects purity and safety. We also examine the major challenge of fouling, where valuable molecules clog the very filters designed to protect them. Finally, we highlight strategies to overcome these obstacles, including prefiltration, advanced membrane materials, and smart process optimization. This episode offers a clear look into the science and innovation shaping the future of biopharma filtration.Featured Article:Â Membrane Technology for Sterilization and Virus Elimination of Biopharmaceuticals: Fouling Matters(https://doi.org/10.1016/j.advmem.2025.100143)
Gene therapies using recombinant adeno associated (rAAV) viral vectors are offering cures for conditions once thought untreatable, but the enormous cost and complex manufacturing keep them out of reach for many patients. In this episode of The BioDisruptors Podcast, we look at a new manufacturing approach that could change the economics of these treatments.Examining recent research from experts in process development, we explore how a multivariate design of experiments boosted viral vector yields to over one trillion vector genomes per milliliter while improving quality. From the science behind vector production to the impact on dose availability and affordability, we break down how smarter process optimization could make large scale, cost effective gene therapy manufacturing a reality.Featured Article:Â High-Yield Recombinant Adeno-Associated Viral Vector Production by Multivariate Optimization of Bioprocess and Transfection Conditions (https://doi.org/10.1002/btpr.3445)
Cell and gene therapies are changing how we treat diseases that were once considered untreatable, but their massive price tags are putting serious pressure on health systems. In this episode of BioDisruptors, we explore whether biosimilars, which are lower cost follow-on versions of biologic drugs, can work for these complex therapies.Using insights from experts across regulation, manufacturing, intellectual property, and pricing, we dive into the real challenges and opportunities for biosimilar development in cell and gene therapy. From unclear FDA rules and clinical trial delays to secretive manufacturing processes and dense patent strategies, we break down what stands in the way of affordable alternativesFeatured Article:Â Introducing Biosimilar Competition for Cell and Gene Therapy Products (https://doi.org/10.1093/jlb/lsae015)
In this episode, we unpack how the Food and Drug Administration speeds up drug development for serious and underserved medical conditions. We explore five key designations that accelerate this process: Orphan Drug, Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy.You will learn how these programs help bring treatments to patients more quickly and how they are driven by both scientific urgency and public policy goals. We also examine the tradeoffs that come with speed, including smaller clinical trials, more post approval safety changes, and significantly higher costs for many of these therapies.Featured Article:Â Special FDA Designations for Drug Development: Orphan, Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy (https://doi.org/10.1007/s10198-023-01639-x)
In this episode, we explore the growing shift in biotech to remove animal derived components from research and manufacturing. Materials like fetal bovine serum (FBS), animal sourced antibodies, and extracellular matrix proteins have long supported cell culture and drug development, but they raise serious ethical, scientific, and safety concerns.We dig into why the biopharma industry is moving toward animal origin free alternatives, the problems with traditional inputs, and the innovative solutions replacing them. From chemically defined media and recombinant antibodies to plant based hydrogels and synthetic matrices, tune in to discover how the future of biopharma is being shaped by consistency, precision, and a stronger commitment to human relevance and animal welfare.Featured Article:Â Animal-Derived Products in Science and Current Alternatives (https://doi.org/10.1016/j.bioadv.2023.213428)
Natural killer cells are gaining serious momentum as a promising form of cell therapy in the fight against cancer. This week, we dive deep into the fascinating world of natural killer (NK) cells, our immune system’s fast acting first responders, and how they are being reengineered to take on some of the toughest cancers. We explore how NK cells work, why cancer manages to evade them, and what researchers are doing to overcome these hurdles, from memory like NK cells to powerful CAR engineered therapies and next generation strategies like bispecific engagers and extracellular vesicles. Tune in to learn how these cellular assassins are being transformed into a new wave of cancer fighting tools.Featured Articles: Natural Killer Cell-Based Cancer Immunotherapy: From Basics to Clinical Trials (https://doi.org/10.1186/s40164-024-00561-z)Building a Better Defense: Expanding and Improving Natural Killer Cells for Adoptive Cell Therapy (https://doi.org/10.3390/cells13050451)
Gene therapies offer real hope for patients with serious conditions like spinal muscular atrophy and sickle cell disease. These treatments can work with just one dose, but that dose can cost more than three million dollars. So how can we make sure patients who need them can actually get them?In this episode of The BioDisruptors Podcast, we explore the challenges of paying for gene therapy. We explain why these treatments are so expensive, how insurance plans are trying to manage the cost, and what new ideas might help, such as paying based on results or spreading payments over time.If you want to understand how science, money, and policy all come together in modern medicine, this episode is for you.Featured Article: Managing the Challenges ofPaying for Gene Therapy:Strategies for Market Action and Policy Reform (https://icer.org/wp-content/uploads/2024/04/Managing-the-Challenges-of-Paying-for-Gene-Therapy-_-ICER-NEWDIGS-White-Paper-2024_final.pdf)
In this episode of The BioDisruptors Podcast, we take a deep dive into the cutting edge world of oral vaccines and break down the science behind why the oral route approach is so promising.However, turning a vaccine into a pill is no small feat. The gastrointestinal tract is designed to break things down, creating a hostile environment for fragile molecules like proteins and mRNA. We explore the major biological barriers and the groundbreaking strategies scientists are developing to overcome them.Join us as we unpack the promise, the challenges, and the biotech innovations shaping the future of vaccine delivery.Featured Article: Oral Biologic Delivery: Advances Toward Oral Subunit, DNA, and mRNA Vaccines and the Potential for Mass Vaccination During Pandemics (https://doi.org/10.1146/annurev-pharmtox-030320-092348)
In this episode, we’re celebrating a major milestone for food innovation. Wildtype has officially received FDA clearance for its cultivated salmon; the first cultivated seafood ever approved for sale in the United States.What makes this especially exciting is how closely the cultivated meat process mirrors the workflows of biopharma. From cell isolation to bioreactor scale-up and media optimization, the tools used to grow meat from cells are straight out of the life sciences playbook.We explore how Wildtype and others are navigating the scientific, technical, and regulatory challenges of bringing cultured protein to market and what this means for the future of sustainable food production.Featured Article: Current Technology and Industrialization Status of Cell-Cultivated Meat (https://pmc.ncbi.nlm.nih.gov/articles/PMC11007461/)
In this week's episode, we tackle another complex and critical challenge in gene therapy manufacturing: purifying recombinant Adeno-Associated Virus (AAV). Why is it so important to separate full capsids from empty ones—and how can we do it more effectively?Join us as we revisit the fundamentals of chromatography and explore the cutting-edge role of mechanistic modeling in optimizing downstream purification. This episode bridges biology, engineering, and computation to reveal how smarter purification strategies lead to safer, more effective gene therapies.Featured Article: Mechanistic Modeling of Empty-Full Separation in Recombinant Adeno-Associated Virus Production Using Anion-Exchange Membrane Chromatography (https://doi.org/10.1002/bit.28595)Separation Techniques: Chromatography (https://doi.org/10.14744/nci.2016.32757)
In this new episode of The BioDisruptors Podcast, we take you inside one of biotech’s most exciting frontiers: artificial intelligence in biopharmaceutical manufacturing. Moving past the headlines, they explore how AI is making a real impact: from optimizing upstream and downstream bioprocesses to enabling real-time quality control, predictive maintenance, and supply chain resilience.Featured Article: Using Deep Reinforcement Learning for Optimizing Process Parameters in CHO Cell Cultures for Monoclonal Antibody Production (https://doi.org/10.69987/AIMLR.2024.50302)Advancements in Manufacturing Technology for the Biotechnology Industry: The Role of Artificial Intelligence and Emerging Trends (https://dx.doi.org/10.22161/ijcmp.8.2.3)
For decades, the biopharma industry has relied on horseshoe crab blood to detect dangerous bacterial endotoxins. But with growing ethical, environmental, and scientific concerns, the tides are shifting.We explore the history of pyrogen testing, from rabbit injections to the LAL test, and unpack the science behind these methods. Then, we turn our focus to the emerging recombinant technologies that promise greater specificity, consistency, and sustainability; all without relying on animal sources.Most importantly, we break down the new U.S. Pharmacopeia <86>, a major regulatory milestone that officially recognizes recombinant endotoxin tests as compendial methods. What does this mean for manufacturers? For regulators? And for the horseshoe crabs?If you're in biotech, pharma, or medical devices, or just curious about how injectable drugs are kept safe, this is an episode you won't want to miss.Featured Article: Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing (https://journals.sagepub.com/doi/10.1177/02611929231204782)
Delivering gene therapies to the brain is one of the toughest challenges in biotech. But what if we could hijack the body’s own transport system to do it?In this episode, we dive into a 2016 study on exosome-associated AAV vectors; a clever fusion that improves AAV delivery to the central nervous system. By packaging AAVs inside naturally occurring exosomes, researchers demonstrated enhanced transduction efficiency across the blood-brain barrier, with reduced immune response and broader tissue reach.We explore the mechanisms, the implications for non-invasive CNS gene therapy, and what this means for future treatments in neurology and beyond.Featured Article: Exosome-Associated AAV Vector as a Robust and Convenient Neuroscience Tool (https://pubmed.ncbi.nlm.nih.gov/26836117/)
Formulating biologics is one of the most complex steps in drug development, requiring a deep understanding of molecular stability, delivery mechanisms, and regulatory constraints. This episode delves into the intricacies of excipient selection, aseptic manufacturing, and advanced delivery systems like lipid nanoparticles. We explore how formulation choices impact clinical performance and the future of personalized biologic therapies.Featured Articles: Optimizing Excipient Properties to Prevent Aggregation inBiopharmaceutical Formulations (https://doi.org/10.1021/acs.jcim.3c01898)Optimizing Your Biologic Drug Formulation Strategy (https://www.bioprocessonline.com/topic/optimizing-your-biologic-drug-formulation-strategy)
Wondering how new medicines are discovered and brought to life? We explore the fascinating world of drug discovery — the critical first step in creating new therapies. We’ll walk through how researchers identify, design, and validate treatments, from early scientific breakthroughs to the complex process of developing New Biological Entities (NBEs). You'll discover the immense time, cost, and innovation it takes to bring a drug from the lab bench to patients. Whether you’re a biotech enthusiast or simply curious about how new medicines come to life, this episode offers a deeper appreciation for the science that changes lives.Featured Articles: Drug Discovery and Development: Role of Basic Biological Research (https://doi.org/10.1016/j.trci.2017.10.005)The Stages Of Drug Discovery And Development Process (https://doi.org/10.5281/zenodo.10816178)
In this episode of The BioDisruptors Podcast, we dive into the art and science of assay development; a critical, yet often overlooked, part of the drug discovery pipeline. We explore Solute Carriers (SLCs), what makes a “good” assay and how thoughtful assay design drives reliable, reproducible results in biopharma research. Along the way, we discuss insights from the Assay Guidance Manual, a gold-standard resourced developed by NCATS and Eli Lilly, and break down findings from a recent Frontier in Pharmacology titled “Advancing drug discovery through assay development: a survey of tool compounds within the human solute carrier superfamily.”Whether you’re new to assay development or just want a refresher on best practices, this episode delivers practical insights with real-world relevance. Featured Publications: Advancing Drug Discovery Through Assay Development: A Survey of Tool Compounds within the Human Solute Carrier Superfamily (https://doi.org/10.3389/fphar.2024.1401599)Assay Guidance Manual (https://www.ncbi.nlm.nih.gov/books/NBK53196/)
In this episode, we dive into the most commonly used viral vector in gene therapy—Adeno-Associated Virus (AAV). We're breaking down a recent Nature review article published in Signal Transduction and Targeted Therapy, which highlights the latest progress and persistent challenges in AAV-based gene therapies.Tune in for a deep dive into the science and the road ahead for AAV in biotech.Review Article: Adeno-Associated Virus as a Delivery Vector for Gene Therapy of Human Diseases (https://doi.org/10.1038/s41392-024-01780-w)
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