Dual-Stage Cross-Flow Filtration: Integrated Capture and Purification of Virus-Like Particles.

Virus-like particles (VLPs) are a versatile technology for the targeted delivery of genetic material through packaging and potential surface modifications for directed delivery or immunological issues. Although VLP production is relatively simple as they can be recombinantly produced using microorganisms such as Escherichia coli, their current downstream processing often relies on individually developed purification strategies. Integrating size-selective separation techniques may allow standardized platform processing across VLP purification.

RP-CAD for Lipid Quantification: Systematic Method Development and Intensified LNP Process Characterization.

Lipid nanoparticles (LNPs) and their versatile nucleic acid payloads bear great potential as delivery systems. Despite their complex lipid composition, their quality is primarily judged by particle characteristics and nucleic acid encapsulation. In this study, we present a holistic reversed-phase (RP)-charged aerosol detection (CAD)-based method developed for commonly used LNP formulations, allowing for intensified LNP and process characterization.

Raman-based PAT for VLP precipitation: systematic data diversification and preprocessing pipeline identification.

Virus-like particles (VLPs) are a promising class of biopharmaceuticals for vaccines and targeted delivery. Starting from clarified lysate, VLPs are typically captured by selective precipitation. While VLP precipitation is induced by step-wise or continuous precipitant addition, current monitoring approaches do not support the direct product quantification, and analytical methods usually require various, time-consuming processing and sample preparation steps.

Process monitoring framework for cross-flow diafiltration-based virus-like particle disassembly: Tracing product properties and filtration performance.

Virus-like particles (VLPs) are an emerging biopharmaceutical modality with great potential as a platform technology. VLPs can be applied as gene therapy vectors and prophylactic or therapeutic vaccines. For non-enveloped VLPs, recombinant production of the protein subunits leads to intracellular self-assembly.

Process development for cross-flow diafiltration-based VLP disassembly: A novel high-throughput screening approach.

Virus-like particles (VLPs) are particulate structures, which are applied as vaccines or delivery vehicles. VLPs assemble from subunits, named capsomeres, composed of recombinantly expressed viral structural proteins. During downstream processing, in vivo-assembled VLPs are typically dis- and reassembled to remove encapsulated impurities and to improve particle morphology.

Integrated Process for Capture and Purification of Virus-Like Particles: Enhancing Process Performance by Cross-Flow Filtration.

Virus-like particles (VLPs) are emerging nanoscale protein assemblies applied as prophylactic vaccines and in development as therapeutic vaccines or cargo delivery systems. Downstream processing (DSP) of VLPs comes both with challenges and opportunities, depending on the complexity and size of the structures. Filtration, precipitation/re-dissolution and size-exclusion chromatography (SEC) are potent technologies exploiting the size difference between product and impurities.