Panning the Golden Batch A bioprocessor can monitor key attributes on the way to producing a therapy. Picking the right attributes to assess, however, can make the difference between a failed product or achieving a gold-medal treatment. The FDA's Nicholas Trunfio, PhD, and his colleagues mapped out a path to so-called “golden batches,” which meet or exceed all of the critical process parameters.
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Genetic Engineering & Biotechnology News (GEN) is the flagship publication of Mary Ann Liebert, Inc. Celebrating its 40th anniversary in 2021, GEN was the first publication in this field and remains the key driver in the explosion of the industry, paving the way for the development of new tools and technologies, investment growth, and career opportunities. Through its cornerstone Magazine, dynamic Website, high-frequency eNewsletters, and innovative suite of multimedia, GEN is the 360-degree resource that researchers and executives depend on for information that is pivotal for their success. GEN’s breadth of editorial coverage is unrivaled, providing exclusive reporting, insight, and analysis across the life sciences – from its five foundational pillars of Drug Discovery, Bioprocessing, OMICS, Translational Medicine, and Gene Editing to a new, expanded focus on the emerging areas of Cancer Research, Infectious Diseases, and Artificial Intelligence. Within these areas, GEN delivers exclusive, high-quality reporting on the latest industry news; insider information on cutting-edge tools and technologies; industry-standard protocols, tutorials, and technical articles; first-looks at emerging industry collaborations and investments; reports from key scientific and industry meetings; and A-Lists, our monthly insight and analysis into the top companies, products, and movers & shakers impacting the industry today.
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Updates
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Super-Resolution Microscopy More Than Pretty Pictures Nanoscopy technology can drive biological discovery not just with imagery, but also with meaningful quantitative data.
Super-Resolution Microscopy More Than Pretty Pictures
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Peptide-Guided Nanoparticles Deliver mRNA to Neurons This breakthrough marks a significant step toward potential next-generation mRNA treatments for neurological diseases like Alzheimer’s and Parkinson’s, according to the University of Pennsylvania researchers.
Peptide-Guided Nanoparticles Deliver mRNA to Neurons
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NVIDIA's Venture Arm Raises Stake in AI Drug Discoverer Genesis Therapeutics NVentures invests further in Stanford spinout to accelerate development of platform designed to optimize molecules for complex targets in oncology, immunology.
Nvidia's Venture Arm Raises Stake in AI Drug Discoverer Genesis Therapeutics
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How the Inflammatory Process Is Influenced by the Circadian Rhythm Research from the Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences reveals macrophages work at differently at various times and could pave the way for time-targeted treatments for inflammatory diseases. The research also reveals mitochondria’s role in driving daily changes in immune activity.
How the Inflammatory Process Is Influenced by the Circadian Rhythm
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Ketamine Keeps Zebrafish from Giving up by Overstimulating Astroglia Researchers showed that ketamine overstimulates astroglia in the zebrafish brain to suppress the animals’ “giving up” behavior. The findings from Howard Hughes Medical Institute (HHMI) Janelia Research Campus, Harvard University, and The Johns Hopkins University could help researchers get a clearer picture of how antidepressants work in the brain, potentially leading to safer, more effective drugs to treat depression.
Ketamine Keeps Zebrafish from Giving up by Overstimulating Astroglia
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POV from the December Issue: Overcoming the Plague of Counterfeit Medications Counterfeit medications encompass drugs that lack the appropriate quantity and quality of the required active pharmaceutical ingredient (API) or contain unwanted Counterfeit medications encompass drugs that lack the appropriate quantity and quality of the required active pharmaceutical ingredient (API) or contain unwanted substances, such as contaminants, erroneous APIs, and expired, repackaged products. Additionally, counterfeit medications can be incorrectly formulated or produced in suboptimal conditions, making them ineffective or even toxic to consumers. These are “out-of-specification products.” Counterfeit medications may also include unregistered and unlicensed drugs (that is, drugs that have not undergone regulatory approvals) or falsified medicines (that is, drugs that have been deliberately and fraudulently misrepresented as to their identity, composition, and source). Fortunately, counterfeit medications are attracting countermeasures, such as those advocated by the Active and Intelligent Packaging Industry Association. To learn about these measures, GEN caught up with the organization’s communications director, Andrew Manly, who had recently attended the Convention on Pharmaceutical Ingredients event that was held in Bangkok in 2024 (CPHI Southeast Asia 2024). Responses to the following questions summarize his views about counterfeit medications. https://hubs.li/Q02_W-hP0
Overcoming the Plague of Counterfeit Medications
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Novel "Protein Cage" Design for Advanced Drug Delivery Systems An international collaboration between researchers at The Centre for Programmable Matter at Durham University (U.K.) and the Malopolska Centre of Biotechnology, Jagiellonian University (Poland) has resulted in the generation of a novel artificial protein cage that holds great promise as an advanced drug delivery system, according to the scientists, who reported their study “Designed, Programmable Protein Cages Utilizing Diverse Metal Coordination Geometries Show Reversible, pH-Dependent Assembly” in Macromolecular Rapid Communications. The team says it has crafted a highly adaptable artificial protein cage, based on a ring-shaped scaffold made of TRAP proteins. These nano-scale structures feature strategically positioned metal-binding sites that enable self-assembly into highly organized structures upon exposure to cobalt or zinc ions. These cages have the potential to carry therapeutic cargo in their hollow core. Most importantly, although highly stable, the cages can be triggered to open up and free their cargoes in certain disease-specific conditions. These include changes in pH, such as those associated with some cancers.https://hubs.li/Q02_WVWJ0
Novel "Protein Cage" Design for Advanced Drug Delivery Systems
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S. aureus Vaccine Failures Linked to Interleukin Production, Antibody Inactivation Staphylococcus aureus is a major cause of skin and soft tissue infections that can sometimes lead to sepsis and toxic shock syndrome. And while many S. aureus vaccine candidates have been effective in mice, approximately 30 human clinical trials have so far failed. Now, a team of UC San Diego researchers and collaborators has identified a potentially key reason for these trial failures, indicating that it may be possible to modify the vaccines to work in humans. In their new study, the researchers reported that S. aureus induces an overabundance of interleukin-10 (IL-10) in B cells, leading to the inactivation of antibodies, and rendering them unable to kill S. aureus. In their paper they concluded, “Overall, we demonstrate a pathobiont-centric mechanism that modulates antibody glycosylation through IL-10, leading to loss of staphylococcal vaccine efficacy.” https://hubs.li/Q02_WYyK0
S. aureus Vaccine Failures Linked to Interleukin Production, Antibody Inactivation
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AI Approach Builds Genomenon's Database of Clinically Relevant Genomic Data As the amount of genomic data grows, so too does the challenge of organizing it into a usable database. Indeed, the lack of a searchable database of genomic information from the literature has posed a challenge to the research community. Now, Genomenon, Inc AI-based approach—the Genomenon Genomic Graph (G3) knowledgebase—combines patient and biological data from nearly all published scientific and medical studies, including demographics, clinical characteristics, phenotypes, treatments, outcomes, and disease-associated genes and variants. Training of the underlying large language model for G3 uses Genomenon’s proprietary, curated genomic datasets. The knowledgebase will power AI-driven predictive models for clinical diagnostics and drug development applications. https://hubs.li/Q02_Wgfl0
AI Approach Builds Genomenon's Database of Clinically Relevant Genomic Data
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