Contaminant Screening

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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

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.

Learn about Determining Residual Bead Count: Application of Micro-Flow Imaging to CAR T-Cell Manufacturing in the application note
The MFI 5000 Micro-Flow Imaging instrument provides accurate detection and quantitation of polystyrene beads in CAR T-cell samples.

 

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.

Learn how Simple Western instruments identify process-related impurities in the Bioprocess Contaminant Detection application note
Simple Western platforms like Peggy Sue detect process-related impurities and contaminants including host cell protein (HCP), Protein A, green fluorescence protein (GFP), and bovine serum albumin (BSA).

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