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.
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
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