Bioprocessing with Octet^®️ Bio-Layer Interferometry

Recombinant adeno-associated virus (rAAV) is one of the most promising viral vectors in gene therapy for genetic disorders. The highly versatile Octet^® BLI platform can be used to design multiple AAV serotype-specific titer assays, as well as a generic assay method for viral titer at-line in a bioprocess setting. We outline the steps and materials needed to establish a fast, high-throughput, and robust AAV2 capsid quantification assay workflow that demonstrates excellent precision and reliability in comparison to ELISA and ddPCR.

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The analytical group at Boehringer Ingelheim, Fremont, USA needed a robust assay to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in their Quality Control (QC) department. The developed Fab activity assay is accurate and robust, with intermediate and intramediate precision less than 10%. Drug activity measurement using the Octet^® BLI system has become a critical parameter for their product evaluation and has resulted in increased Fab drug product consistency and quality.

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The formation of aggregates can affect the efficacy and safety of biologics. While many biophysical analytical tools can detect aggregates, few offer a combination of structural and functional assessment. The Octet^® BLI platform can detect aggregates while monitoring functional activity at the formulation stage of drug development.

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Octet^® BLI instruments can be equipped with 21 CFR Part 11 Software for compliance with regulatory requirements. Compliance is further enhanced with the availability of instrument qualification kits including IQ|OQ and PQ kits that ensure the platform performs as stipulated. This white paper includes a few examples to demonstrate the suitability of BLI technology under GxP compliance for different applications and shows the relative benefits over alternate technologies.

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Host Cell Proteins (HCPs) in finished products can decrease the efficacy of the drug or cause adverse immunogenic reactions.  Partnering with Cygnus Technologies, the Anti-CHO HCP Detection Kit for quantitation of residual HCPs brings the Octet^® BLI systems high throughput analysis together with the broad HCP recognition and sensitivity of the leading Cygnus 3G anti-CHO HCP antibody.

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Scientists at Celgene Corporation developed a screening process incorporating the Octet^® BLI platform. This allows them to identify pools and clones with higher concentrations of bispecific antibodies. High throughput was achieved from the multiple simultaneous measures possible on one system and rapid assays times, such as binding optimization in only 10 minutes.

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Up to 2x faster and with the ability to process 40x more samples per day, Octet^® BLI systems are an ideal replacement for ELISA, HPLC or other label-free techniques for the quantification of antibodies and recombinant proteins and is especially suitable for product potency lot release assays. Boehringer Ingelheim were able to develop an active Fab quantitation assay for in-process testing as well as stability and lot release testing in less than one week using the Octet^® BLI platform.

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Rapid, accurate and cost-effective quantitation of monoclonal antibodies (MAbs) is essential for bioprocessing. Here we assess the relative merits of Protein A High-Pressure Liquid Chromatography (HPLC) and Protein A bio-layer interferometry BLI using an eight-channel Octet^® R8 systems to determine mAb concentration in a complex feedstock.

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The high cost and lengthy times associated with drug discovery and development have forced biopharm companies to improve the efficiency and economics. Biopharmaceutical companies have enthusiastically adopted Octet^® BLI systems due to their broad utility in protein quantitation and functional characterization combined with enhanced throughput, decreased sample preparation requirements, and low cost of operation.

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This app note discusses the strategies for the development and validation of a potency assay using BLI technology. The ease-of-use and fast time to results is highlighted by showcasing a method for evaluating the binding of an Fc gamma receptor III (FcγR) molecule to the widely characterized NIST mAb.

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