> Cell and Gene Therapy Solutions > Contaminant Screening
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.
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 cell expansion components in NK cell products
Particulate contaminants in cell therapy products can arise from several manufacturing processes, including cell expansion. Because contaminants affect drug safety and efficacy, the ability to clearly visualize different types of contaminants and characterize them further is crucial. In the Application Note Assess the Purity of Your Cell Therapy Product with Confidence: Micro-flow imaging for Natural Killer Cell Therapeutics, we describe the use of MFI’s custom filter options for distinguishing NK cells from their expansion components, Cloudz™ Microspheres.
Natural Killer Cells or Contaminant? Imaged based MFI, Sub-Visible Particle Solution, for Cell Therapy
In this 30-minute webinar, learn about the considerations regarding the methodology of NK cells expansion and identifying sources of particle contamination from ancillary materials. Dr. Taketa showcases Micro-Flow Imaging (MFI) as a solution for sub-visible particle analysis to identify and differentiate NK cells from their expansion components, either irradiated K-562 feeder cells or Cloudz™ microspheres, as well as other contaminants. Dr. Daryl Taketa is an Applications Scientist for ProteinSimple, a Bio-Techne brand. Watch On-Demand
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.
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.