Optimize and Monitor Product Integrity

Development of a single drug, whether it is a new chemical entity, biotherapeutic, or cellular therapy, requires significant investment of resources. Care must be taken to choose analytical methods that are fit for the purpose of monitoring products and contaminants in the process. With expertise in labeling and detection, Enzo offers solutions to help rapidly analyze protein stability and integrity for all your bioprocessing needs.

Figure 1: Broadest detection range from visible to subvisible particles

Protein Aggregation
The PROTEOSTAT® Protein Aggregation Assay (ENZ-51023) is a sensitive, homogeneous, fluorescence-based detection assay. The novel molecular rotor dye detects a broad range of different protein aggregates from visible to subvisible particles (Figure 1).

Figure 2A: Detects low % aggregate in concentrated samples

With convenient options for analysis, this high-throughput assay can be used on either a fluorescent microplate reader or flow cytometer. It provides a convenient, complementary orthogonal method for cross-validation of instrumentation-intensive techniques. Figure 2 shows advantages of the PROTEOSTAT® Aggregation Assay, and Figure 3 shows effectiveness over a wide pH range and ionic strengths.

Figure 2B: Brighter than other dyes

In addition, Enzo offers the only commercially available protein aggregation standards: PROTEOSTAT® Protein Aggregation Standards (ENZ-51039). These stabilized, high-quality reference IgGs are provided in known concentrations and complement analysis performed with the PROTEOSTAT® detection reagent.

Figure 3A: Compatible with a wide range of buffer ionic strengths

Figure 3B: Lysozyme detection as a function of pH

Miriam Cortes-Caminero is the technical marketing manager at Enzo Life Sciences; www.enzolifesciences.com.