Undetected process-related impurities in pharmaceutical products originating from the production cell line, reagents used for cell culture/maintenance, or during downstream processing can lead to decreased product efficacy, quality issues and undesirable immune responses in patients. ProteinSimple platforms can help you accurately identify and differentiate between potential sources of bioprocess contaminants like polystyrene beads, host cell protein (HCP), and bovine serum albumin (BSA) to confirm the quality and stability of your therapeutic.
Cell Contaminant Screening
Micro-flow Imaging (MFI) gives you morphological data on subvisible particles in your therapeutic products. Detect contaminants in your cell therapy products, including residual cell expansion products. By directly imaging particles, MFI gathers rich morphological data and uses powerful software tools to classify different particle types in solution.
Detect residual beads in CAR-T cell products
Removing polystyrene beads during activation and expansion of T cells is critical to ensuring the safety and purity of the chimeric antigen receptor T cell (CAR T-cell) product. In our Application Note, Determining Residual Bead Count: Application of Micro-Flow Imaging to CAR T-Cell Manufacturing, learn how Micro-Flow Imaging (MFI) can be used to provide accurate detection and quantitation of even low numbers of beads in a CAR T-cell sample to improve safety in patients who are compromised.
Bioprocess Contaminant Detection
Identify process-related impurities
Accurate identification and quantitation of residual impurities is complicated by the range of potential sources, types, trace amounts present and complex sample matrices. In this Application Note, Bioprocess Contaminant Detection, learn how Simple Western platforms detect HCP, Protein A, green fluorescence protein (GFP) and BSA in denatured and reduced samples, with the sensitivity needed to confirm if their concentration falls below regulatory guidelines. These systems automate the process start to finish, and also capture critical information on sizing and oligomerization, giving you more flexibility to build a comprehensive contaminant profile.