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Titer & Impurity Testing

  • Screen samples during cell line development
  • Monitor titer production from bioreactors
  • Determine dynamic binding capacity of affinity resins on packed chromatographic 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
Efficiency in process development of biologics

Overview for Titer & Impurity Testing

The desire to minimize costs for the production of biopharmaceutical drugs while maintaining high standards of quality and safety means that companies are constantly in search of 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 purification columns dynamic binding capacity assessment, product contaminant testing, titer, etc, analytical techniques that enhance efficiencies while maintaining quality are critical to the development of biopharmaceutical drugs.

Titer and protein quanituion

Titer and protein quantitation on the Octet system

Octet systems are a suitable replacements for ELISA and HPLC techniques in the quantitation of antibodies and recombinant therapeutic proteins. They are high throughput, accurate, fast, and are easy to use allowing for easy development and transfer of methods to QC and manufacturing.

 
  • Analyze a full plate (96-samples) of IgG titer in as little as two minutes
  • Sample plate format allows for the use of crude and non-purified samples
  • Automation capable Octet HTX and Red 384 allow for walkaway high throughput analysis
  • Readily accommodates the use of DOEs to rapidly develop robust potency measurement methods
Residual protein A

Impurity testing - Residual Protein A (RPA) detection on the Octet system

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

 
  • Designed to detect recombinant Protein A constructs and MabSelect SuRe™
  • Accurate quantitation down to 100 pg/mL recombinant Protein A
  • Automated detection with minimal hands-on time
  • Analyze 96 samples in under two hours on the Octet HTX system
  • Optimized and validated assay
Host cell protein

Impurity testing – Host Cell Protein (HCP) detection on the Octet system

Host Cell Proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines that may copurify with the drug product during purification and that can carry substantial risk of decreasing efficacy of the drug. In addition, they could cause adverse immunogenic reactions in patients making their detection crucial.

ForteBio and Cygnus Technologies have jointly developed the Anti-CHO HCP Detection Kit for quantitation of residual HCPs. The Octetsystem's rapid high throughput protein analysis combined with the broad HCP recognition and sensitivity of the industry-standard Cygnus 3G anti-CHO HCP antibody bring scientists the best of both worlds for HCP analysis.

 
  • 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

Resources of Titer & Impurity Testing

Application Note Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. UV spectroscopy, ELISA and HPLC have been in use for decades for protein quantitation in physiologi- cal and process samples, and continue to be the workhorses despite their many limitations. Read more

Application Note Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control

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 four-hour assay time of their ELISA protocol, the Octet assay provided an analysis time of only one hour per 96-well microplate, including sample preparation time. This Octet assay was used to monitor Fab activity for all process development studies.

Read more

Technical Guide CHO Host Cell Protein Detection

Host cell proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines. Among protein expression cell lines, Chinese hamster ovary (CHO) cells are the most commonly used mammalian hosts for industrial production of recombinant protein therapeutics

Read more

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