Avsnitt
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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)
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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/)
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Saknas det avsnitt?
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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)
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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)
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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/)
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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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In this episode, we take a deep dive into the engineering fundamentals of bioprocessing, focusing on how key engineering parameters—mixing time, power input per volume (P/V), and oxygen transfer rate (kLa)— impact cell culture performance. We’ll explore a study that investigates how these dynamics play out specifically in the WAVE bioreactor, compared to traditional stirred-tank bioreactors.
White Paper: Engineering Characterization of ReadyToProcess WAVE 25 Bioreactor System with 20 L Cellbag Culture Chamber
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Perfusion technology for intensifying virus manufacturing processes for animal vaccines. The study investigated the impact on cell density and viral output across different scales and cell lines.
White paper: Investigation of XCell ATF® Perfusion Technology for virus
manufacturing process intensification at MSD Animal Health
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The BioDisruptors Podcast Launch!
Listen now and turn biotech complexity into clarity.
