Bioprocess Titer & Impurity Testing

Replacing HPLC Quantitation for Titer, HCP, and RPA

  • Screen samples during cell line development
  • Monitor titer production from bioreactors
  • Determine dynamic binding capacity of affinity resins on packed chromatography columns and characterize the purified product
  • Quickly detect and monitor potential process generated contaminants such as Host Cell Proteins and Residual Protein A with better precision and robustness than traditional ELISAs

Minimizing costs during the production of biopharmaceutical drugs while maintaining high standards of quality and safety has created the need for technologies that can simplify the drug development workflow and reduce the time to results.

From upstream processes such as cell line development to downstream processes like dynamic binding capacity assessment of purification columns, product contaminant testing, and titer, the analytical capability of the Octet platform is enhancing efficiencies and maintaining quality during the development of biopharmaceutical drugs.

Features

Titer and Protein Quantitation

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.

  • Analyze a full plate (96-samples) of IgG titer in as little as two minutes
  • Assay directly in crude and unpurified samples
  • Optional automation for walkaway high throughput analysis

Impurity Testing – Host Cell Protein (HCP) Detection

Host Cell Proteins (HCPs) are expressed in bacterial, yeast, and mammalian production cell lines that can copurify with the drug product during purification.  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 system's high throughput analysis together with the broad HCP recognition and sensitivity of the Cygnus 3G anti-CHO HCP antibody.

  • Complete hands-off, walkaway HCP analysis
  • Fully analyzed HCP results for 96 samples in one hour
  • High precision assays with 5-10% CVs
  • Detection sensitivity as low as 0.5 ng/mL

Download Technical Guide

Impurity Testing - Residual Protein A (RPA) Detection

The Ready BLI Detection Kit - Residual Protein A (RPA) enables simple, sensitive, and accurate quantitation of leached Protein A in bioprocess samples. The kit utilizes a validated sample treatment method for dissociating Protein A from antibodies that does not require boiling, neutralization, or centrifugation steps.

  • Detect recombinant Protein A constructs and MabSelect SuRe™
  • Accurate quantitation down to 100 pg/mL recombinant Protein A
  • Analyze 96 samples in under two hours on the Octet HTX system

Download Datasheet

Resources

Customized Quantitation of Recombinant Therapeutic Proteins

Using High Precision Streptavidin Biosensors (SAX)

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diagram

Validated Quantitation and Activity Assay of Fab Molecule for...

The group was able to develop a working Fab activity assay on the Octet RED system in less than a week. Relative to the overnight incubation and...

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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.

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Enhancing Efficiency and Economics in Process Development and...

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing...

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CHO host cell protein detection

CHO Host Cell Protein Detection

Host cell proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines. Among...

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Performing Quantitation Assays Using BLItz System

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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 (Protein 1) in crude cell culture...

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Accelerating Antibody Discovery by Monitoring Titer and...

Significantly reduce time to develop antibodies by combining titer and glycan screening

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Pioneer FE SPR System

Pioneer FE SPR System

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Pioneer SPR System

Complete solution for biomolecular interaction analysis with next generation SPR injections

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Octet HTX

96-Channel Ultra High Throughput Octet System: Octet HTX

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 RED384

The Octet RED384 16-channel instrument provides analytical performance similar to the 8- channel Octet RED96 system, but with higher levels of...

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8-Channel Octet System: Octet RED96e

The 8-channel Octet systems perform quantitation of 96 samples in 32 minutes and kinetic screening of 64 samples in 1.5 hours.

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Unmatched versatility for discovery, development, and quality control

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