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  • Implementing cGMP Potency Assays in PROTAC Drug Development

    Related News – Marin Bio Successfully Passes FDA Inspection & Expands Services What are PROTACs? Proteolysis Targeting Chimeric (PROTAC) drugs are innovative molecules that utilize the ubiquitin-proteasome system to selectively degrade specific proteins within cells. PROTACs are one of the most promising methods for targeted protein degradation (TDP), which is used to remove disease-causing or disease-associated….

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  • Expanding the Toolbox of PROTAC Degraders with Covalent Ligands for Genetically Validated Targets

    Illustration of the ubiquitin-proteasome system tagging and degrading a protein, a process similar to PROTAC drug action

    What are PROTAC degraders or protein degrader drugs? Proteolysis Targeting Chimeric (PROTAC) drugs are a type of novel heterobifunctional molecules that utilize the ubiquitin-proteasome system to selectively degrade specific proteins in cells. Typical PROTAC drugs are composed of a ligand for the protein-of-interest (POI) or target protein and a ligand for E3 ubiquitin ligase, where….

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  • Expanding the Eligibility for AAV Gene Therapy with Monoclonal Antibodies

    Gene therapy has emerged as a promising approach to treating rare genetic disorders and unmet medical needs. Adeno-associated virus (AAV)-based gene therapy is the leading platform for gene delivery; however, the natural prevalence of humoral immunity against AAV in humans limits the population of patients who can benefit from this therapy. A recent study from….

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  • Capsid engineering of adeno-associated virus (AAV) vectors

    Invention: The researchers from Adverum Biotechnologies. (Redwood City, CA) have developed a method for generating eukaryotic cell libraries for screening mutant AAV capsid proteins. Background of the invention Delivering therapeutic drugs via viral vectors is a potential strategy for treating and preventing various human diseases and genetic disorders. Since wild-type AAVs are nonpathogenic and have….

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  • Single-dose immunogene therapy – A universal alternative for CAR-T cell therapy

    Single-dose Immunogene Therapy

    Immunogene therapy is a combination of two different treatment methods: gene therapy and immunotherapy. In immunogene therapy, a protein/antibody, gene, or nucleic acid molecule is delivered to patients by gene therapy methods with the intention of inducing targeted immunomodulatory effects. Recently, researchers have developed a novel cancer immunogene therapy method that overcomes the limitations of….

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  • Immunogenicity assays for adeno-associated virus (AAV)-based gene therapy

    Immunogenicity assays are designed to determine the immune response to biotherapeutics such as protein, peptide, antibody, oligonucleotide or DNA/RNA-based drugs and its clinical impact. In a recent IQ Consortium industry white paper published in the journal Molecular Therapy, researchers provided a framework for bioanalytical strategies related to the immunogenicity assessment of recombinant adenovirus associated virus….

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  • Long-COVID Neuropsychiatric Symptoms May Be Due to Astrocyte Infection

    Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected hundreds of millions of individuals worldwide, disrupting public health and the economy. Post-COVID (or Long-COVID), the collection of symptoms and pathophysiologies that occur in patients after an initial COVID infection encompasses a vast assortment of systems including cardiac, digestive, vascular, and others. Of particular interest has….

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  • Promising New Omicron BA.5 Research Lends HOPE

    As new cases of COVID-19 soar, experts warn about the newly emerged COVID subvariant BA.5, a sub-lineage of BA.2. Subvariants of Omicron BA.1 emerged in 2021, BA.2 in early 2022 and BA.5 came in April 2022. BA.5 dominates globally, replacing BA.2. The BA.1 and BA.2 attach the upper respiratory tract, whereas, the BA.5 damages the….

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  • Long COVID Detected By Cell-Based Assay

    What is long COVID? There have been over half billion cases of SARS CoV-2 (COVID-19) globally since the pandemic began. The majority of infected persons have been either asymptomatic or have experienced a mild acute infection from which they recover within a few weeks. However, some, even those who had mild cases, suffer symptoms that….

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  • Drug Lot Release Potency Assay / Testing

    Why have Lot Release Potency Testing? The US FDA requires that licensed products pass critical analysis before release by the manufacturer for clinical use. These include potency, sterility, purity and identity. Potency is used to ensure consistency and efficacy in the manufacturer’s product used for stability and lot release. A Potency Assay is typically reported….

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