Bioprocess Titer and Impurity Testing
Replacing HPLC and ELISA Quantitation for Titer, HCP and RPA
- Screen samples during cell line development
- Monitor product titer from bioreactors
- Determine dynamic binding capacity of affinity resins on packed chromatography columns and characterize purified product
- Quickly detect and monitor potential process generated contaminants such as Host Cell Proteins (HCP) and Residual Protein A (RPA) with better precision and robustness than traditional enzyme-linked immunosorbent assays (ELISAs)
Minimizing cost 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 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® BLI platform is enhancing efficiencies and maintaining quality during the development of biopharmaceutical drugs.
Titer and Protein Quantitation
Replace ELISA and HPLC with Octet® BLI assays for quantitation of antibodies and recombinant therapeutic proteins. Accurate and fast assays are easy to develop and transfer to quality control (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 extending unattended run times and high throughput analysis
Impurity Testing – Host Cell Protein (HCP) Detection
HCPs often copurify with the drug product when expressed in bacterial, yeast or mammalian cell lines. HCPs in finished products can decrease the efficacy of the drug or cause adverse immunogenic reactions. Partnering with Cygnus Technologies, the Octet®Anti-CHO HCP Kit for quantitation of residual HCPs combines the Octet® BLI system's high throughput analysis with the broad HCP recognition and sensitivity of the Cygnus 3G 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
Impurity Testing - Residual Protein A (RPA) Detection
The Octet® RPA Kit 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® RH96 system