BridgeBio Pharma, Inc., and REGENXBIO Inc. take a novel approach to AAV capsid titer quantification by using Octet® AAVX Biosensors to generate viral titer data.
The rapid development of gene therapies and high demand for therapeutic proteins pose considerable challenges for biomanufacturing. Complex production processes, product changeover, managing supply chains, and staying ahead of the curve, to name just a few. To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. The solution could be a comprehensive approach for screening and characterizing molecular interactions such as protein-protein or protein-drug interactions. It enables a huge variety of applications performed at various stages of biologics development — from early selection to validation to manufacturing. Based on Bio-Layer Interferometry (BLI), it enables real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Download this eBook to learn how the Octet® BLI platform can streamline workflows, reduce time-to-results, and costs saving on broad range of analytical applications in bioprocessing.
Webinar Date/Time: Wednesday, March 29th 2023 7am PDT | 10am EST | 4pm CEST
Adeno-associated virus (AAV) is a widely used viral vector for the delivery of genetic material in gene therapy. Vector development and production at an industrial scale requires an efficient method for accurate quantification of viral capsids. Unfortunately, traditional techniques such as ELISA, HPLC, and ddPCR are time consuming and labor-intensive. This podcast introduces a rapid, label-free method for the direct capture and quantitation of various AAV serotypes using the Octet® Bio-Layer Interferometry (BLI) platform with Octet® AAVX Biosensors. These biosensors deliver results in as little as 15 minutes and can be used to quantitate AAV capsids in both crude and purified samples.
A completely hands-off, walk-away HCP assay analyzing 96 samples can be set up to run automatically on an Octet® RH96 instrument with results obtained in one hour.
To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. Octet® BLI systems enable real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Based on Bio-Layer Interferometry (BLI), the systems enable an enviable variety of applications throughout biologics development, from early selection to validation and manufacturing. Read on to learn about the implementation in the production of biotherapeutics for titer, host cell protein analysis, residual protein detection, sialic acid content detection, potency assay development, Fab activity assay development, and more.
A more streamlined technique with reduced hands-on time using the Octet® platform. For customers who require a sensitive and robust assay for measuring small amounts of leached Protein A in antibody or Fc-fusion protein samples.
Replace ELISA and HPLC with Octet® systems for quantitation of antibodies and recombinant therapeutic proteins. Accurate and fast assays are also easy to develop and transfer to QC and manufacturing. In this whitepaper you will learn about analyzing a full plate (96-samples) of IgG titer in as little as two minutes, assay directly in crude and unpurified samples, and automation for extending un-attended run times and high throughput analysis.
In this White Paper, Sartorius outlines the challenges of scaling a bioprocess and presents solutions to maintain control over critical quality attributes.