Foam is more than just a nuisance! In large-scale biomanufacturing, it is a multibillion-dollar risk. This episode explores how "foaming out" can jeopardize sterility and kill the cell cultures responsible for life-saving drugs.
We examine the high-stakes trade-off between foam control, cell health, and productivity. We also look at the shift toward optical monitoring, a non-invasive technology that is replacing outdated sensors to ensure process stability and maximize yield.
Featured Article: Measurement and Control of Foam Generation in a Mammalian Cell Culture
(https://doi.org/10.1002/btpr.3450)
This week, we explore the critical yet often overlooked world of lyophilization, better known as freeze drying. While you might associate it with astronaut food, it is actually the backbone of the modern pharmaceutical supply chain, stabilizing everything from mRNA vaccines to life saving biologics.
We break down how the industry is ditching inefficient, decades old batch processing for a revolutionary suspended vial continuous system. By suspending vials individually, manufacturers can eliminate the effect of uneven heating, ensuring every single dose experiences identical physics.
Featured Article:Â Mechanistic Modeling of Continuous Lyophilization for Biopharmaceutical Manufacturing
(https://doi.org/10.1002/advs.202511693)
In this episode, we break down the truth about DMSO in cell therapy, how it works, why it is used, and what the data really says about its safety. Drawing from a comprehensive review of more than 1100 patients, we explore infusion reactions, dose thresholds, and common misconceptions around DMSO toxicity. We also discuss pharmacokinetics, including the half life of DMSO, urinary elimination, and its metabolism into dimethyl sulfide. Whether you are in biotech, manufacturing, or clinical development, this episode offers a clear and evidence based look at one of the most misunderstood ingredients in regenerative medicine.
Featured Article:Â Dimethyl Sulfoxide in Cryopreserved Mesenchymal Stromal Cell Therapy Products: Is there a Safety Risk to Patients?
What if we could test new drugs and study diseases without using animals? In this episode, we dive into the world of organoids, mini organs grown from human cells that are reshaping biomedical research. We unpack how these tiny living systems mimic real human tissue, offering scientists a more accurate and ethical way to study biology and develop new treatments. From breakthroughs in drug testing to the promise of personalized medicine, this episode explores how organoids are driving a revolution in science that is both smarter and more humane.
Featured Article:Â Replacing Animal Testing with Stem Cell-Organoids : Advantages and Limitations
Can X ray sterilization really replace gamma irradiation for single use biopharma components? In this episode, we explore a recent study that directly compares the two methods across single-use bioprocessing polymers. The findings are surprising. X ray achieved the same sterilization performance as gamma while running at lower peak temperatures and creating no new extractables or measurable radioactivity.
We also discuss what this means for supply chain flexibility, material stability, and the future of sterilization in biomanufacturing. The conversation clears up common misconceptions and includes insights from the scientists who led the research.
Featured Article:Â Impact of X-ray Irradiation as an Equivalent Alternative to Gamma for Sterilization of Single-Use Bioprocessing Polymers
In this episode of The BioDisruptors Podcast, we explore what it really means to make biologics sustainable. We uncover surprising facts about where the biggest environmental impacts actually come from. It is not the plastic waste most people think of, but the electricity that powers clean rooms and HVAC systems, making up most of the footprint. We discuss how shortening process durations, increasing yields, and switching to renewable energy can dramatically lower emissions while also cutting costs. The conversation shows how sustainability and profitability can go hand in hand, creating a future where greener manufacturing also means greater access to life saving medicines.
Featured Article:Â Streamlined Life Cycle Assessment of Single Use Technologies in Biopharmaceutical Manufacture
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.Â
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
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
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
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
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 alternatives
Featured 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.Â
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)