Bioprocess Protein Residue Detection Using Simple Western
Screening for process related impurities like host cell protein contamination during bioprocess development is critical to demonstrating the quality, efficacy and safety of a biotherapeutic. Contaminating protein residue can be recognized as foreign antigens in vivo, triggering a potentially fatal immune response. Bioprocessing integrated solutions are needed to detect process-related impurities to accelerate process development and streamline
The Simple Western™ family is made up of automated, capillary-based immunoassay platforms that combine the power of CE-SDS or cIEF with the sensitivity of immunodetection using conventional antibodies. Overcome the challenges of traditional ELISA without compromising sensitivity and reduce hands-on time to just 30 minutes. Simple Western provides at-line or near-line measurements of process related impurities and fast, actionable results..
- Simple Western needs only 3 μL of sample, minimizing impact on final product titers.
- Separate and analyze proteins by immunoassay or total protein content.
- Analyze crude or purified samples for proteins of interest or bioprocess contaminants.
- Quantitate protein expression, isoforms, and fragmentation in a gel- free, blot-free, hands-free format.
- Choose from five instruments of differing throughput and separation mode options.
Process Related Impurities
Process Related Impurities
Current methods for assessing the concentration of process related impurities, like ELISAs, flow cytometry, and traditional Western blotting are labor-intensive and prone to error. Highly sensitive Simple Western immunoassays deliver accurate detection of residual proteins resulting from therapeutic protein and vaccine development processes like host cell protein (HCP) contamination, Protein A, GFP, and bovine serum albumin (BSA).
Empty/Full Content Ratio
Empty/Full Content Ratio
In addition to host cell protein residue, empty AAV particles are unwanted byproducts during the manufacturing process, but scalable solutions for measuring empty/full AAV particles are limited. Simple Western reproducibly quantifies empty/full AAV capsid content ratio directly in complex samples. This Simple Western assay for empty/full viral vectors can also apply to the capsid content (and stability) of lentivirus!
Host Cell Impurity Analysis
Host Cell Impurity Analysis
Host cell protein (HCP) contamination is traditionally monitored by ELISA using an anti-HCP antibody or by SDS-PAGE with total protein staining. Simple Western does both! Anti-HCP antibodies may be used on Simple Western with the added advantage over ELISA of size separation profiles and minimal matrix interference. Simple Western also has high-sensitivity total protein assays with sensitivity that rivals SYPRO Ruby.
Upstream and Downstream Bioprocessing Integrated Solutions
Download our eBook for a complete overview of bioprocess workflow solutions from Bio-Techne and discover analytical solutions for you at every step of the bioprocess, from discovery to QC.
