Minimize Cost, Maintain Quality and Safety in Bioprocessing

Bioprocessing

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.

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Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics

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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Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development

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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Downstream Biologics Characterization: Stability, Formulations and Aggregation Studies

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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Enhanced Productivity and Labor Efficiency in Lot Release and In-Process Testing of Biologics

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 whitepaper 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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Potency Assays: Development, Qualification and Validation Strategies

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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CHO Host Cell Protein Detection

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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A Rapid Method to Quantitatively Screen Bispecific Antibody using Protein A and His1K Biosensors Bispecific

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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Modernize Biopharmaceutical QC Testing to Increase Efficiency

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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Mab Quantitation: Protein A HPLC vs. Protein A Bio-Layer Interferometry

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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Rapid, Automated, at-line AAV2 Virus Quantitation Advances Bioprocessing in Gene Therapy

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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Resources

Residual Protein A Detection Kit Datasheet

A simpler, faster alternative to ELISA with reduced hands-on time. A sensitive and robust assay for measuring small amounts of leached Protein A in an...

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Quantitation of Fc-Fusion Protein in Cell Culture Supernatants

The cell line development group at Biogen IDEC needed a robust assay for the measurement of Fc-fusion protein in crude cell culture supernatants.

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Octet® R Series Glycan shadow visual

Mannose Glycans Content Screening for Human-mAb Samples

A novel approach for relative mannose content screening and ranking of human monoclonal antibody (mAb) samples using a well characterized mAb from NIS...

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Octet® SF3 SPR

Octet® SF3 SPR 

Generate high-quality kinetics and affinity data in a fraction of the time compared to standard multi-cycle kinetics using the Octet® SF3.

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Octet® BLI rapidly determines recombinant protein concentration as a control parameter in cell line development.

96-Channel Ultra High Throughput Octet System: Octet® RH96

Monitors up to 96 biosensors simultaneously, enabling label-free detection for protein quantitation and kinetic characterization at unmatched speed

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16-Channel High Throughput Octet System: Octet® RH16

Ideal for high-throughput applications that demand high sensitivity and low sample volume requirements

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8-Channel System: Octet® R8

Unmatched Flexibility and Versatility in Protein Analysis

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