Better Detection Upstream
Maximum Production Downstream

Protein Aggregation
Thermal Shift Stability

Protein A
Host Cell Protein

PEGylated Proteins

Simplify your cell death analysis
Sensitive assays for oxidative stress
Reliable detection of cell line instability
Small Molecules for Bioprocessing Applications

Innovative Tools for Biotherapeutics Development

Development of a single drug, whether it is a new chemical entity, biotherapeutic, or genetic/cellular therapy, requires significant investment of resources. Each step of the process from early discovery through production and delivery must be fully explored, characterized, and understood to prevent issues resulting from cell stress, cell death, protein aggregation, and factors affecting reliable manufacturing of the drug. Whether you work in drug discovery, upstream, or downstream bioprocessing, Enzo offers a range of products to help you maintain cell line viability, optimize and monitor product integrity, and maximize yield.

Featured Tutorial

Optimizing Biologics Formulations : Quantifying Trace Subvisible Protein Aggregates Using a Protein Aggregation Assay and Standards.”
Wayne F. Patton, Ph.D.
Read the tutorial

Small Molecules		ELISA and Detection Kits
Osmotic Stress Modulators		Oxidative Stress
Hybridoma Modulators		Cell Death: Autophagy, Apoptosis, Necrosis
Autophagy Inhibitors		Cell Line Instability
Compound Libraries		IgG ELISA Kits
Toxicity		Contamination Control (Protein A & Host Cell Proteins)
Protease Inhibitors		PEGylated Protein
Bioactives		Thermal Shift (Stability)
Hybridoma Production		Refolding
DiSH Kit		Protein Aggregates
CHO Semi-Solid Media		Biosimilar Conformational ELISAs

Guide to Optimizing Protein Characterization

Current Food and Drug Administration Guidelines
How to Determine Protein Stability
Methods for Detecting Protein Aggregates
Development and Specificity of the PROTEOSTAT® Dye
Using PROTEOSTAT® for a Rapid Detection and Characterization of Protein Aggregates by Flow Cytometry
Detection of Bacterial Aggregates by Flow Cytometry
Using PROTEOSTAT® Reagents to Predict Aggregation
Propensity and Monitor Aggregation of Antibody-Drug Conjugates (ADC)

Optimize and Monitor Product Integrity

PROTEOSTAT® Protein Aggregation Assay

The PROTEOSTAT® Protein Aggregation Assay is a simple, sensitive, homogeneous fluorescent microplate assay. The novel molecular rotor dye used detects a broad range of different protein aggregates from visible to subvisible particles.

Delivers superior results when compared to conventional protein detection dyes (Sypro Orange, Thioflavin T, ANS, Congo Red)
Works over a wide pH and ionic strength range and is compatible with commonly used buffers and excipients
Provides a convenient, complementary orthogonal method for cross-validation of instrumentation-intensive techniques
Useful assay to troubleshoot protein damage, from protein development through manufacturing stages

Reference articles

Optimizing Biologics Formulations
Here and There on Upstream Processing

PROTEOSTAT® Thermal Shift Stability Assay

The PROTEOSTAT® Thermal Shift Stability Assay is a rapid, simple screening method based on a novel molecular rotor dye which detects protein aggregation. The assay does not require any prior knowledge of protein structure, sequence or ligand binding activity, and is performed on a thermally regulated fluorimeter or RT-PCR instrument. A related kit is available for the screening of optimal protein refolding parameters.

Reference articles

Here and There on Upstream Processing

Perform accelerated screening for protein stability as a function of pH, ionic strength, and concentration
Screen for ligand binding to proteins of unknown function
Screen protein variants to determine their relative stabilities or excipients to determine optimal protein storage conditions
Identify protein-protein interaction inhibitors
ProteoStat® dye is tolerant of detergents and hydrophobic compounds

Contamination Monitoring

Protein A ELISA Kit

The Protein A ELISA kit is a sensitive and reproducible sandwich assay to quantify Protein A residuals in monoclonal antibody preparations. This extensively validated ELISA kit enables efficient detection of natural and recombinant Protein A constructs with up to 100% recovery.

Detects 1ppm of Protein A residuals in human IgG
Recognizes 4 different Protein A variants
Useful for contamination analysis and measurement of Protein A variants in monoclonal antibody preparations
Produces results in less than 3 hours with low cost per test

Host Cell Protein ELISA Kits

The Host Cell Protein ELISA kits and reagents are ideal for impurity analysis, Host Cell Protein quantitation and Western blots.

Quantitatively measures host cell protein contamination in E.Coli and CHO derived biologics
Manufactured under cGMP to ensure quality and consistency
High throughput format with results in 2.5 hours

Improved Screening for Biotherapeutic Candidates

PEGylated Protein ELISA Kit

The sensitive PEGylated Protein ELISA kit is ideal for drug development and pharmaceutical manufacturing applications including drug formulations, pharmacokinetics analysis, drug comparison, lead candidate identification, lot release criteria and in-process QC studies.

Validated for a wide range of MW linear and branched PEGs, both in free form and when conjugated to proteins
Sensitive assay measures < 1ng/ml of PEGylated molecules
Quantifies PEGylated target molecules in complex matrices to allow monitoring of drug levels or its accumulation in tissue
High throughput format allows analysis of up to 35 samples in duplicate in just 2 hours

Sensitive detection of linear and branched PEG molecules

Complete Solutions for Process Optimization

Environmental variations in cell culture conditions can lead to cell line instability, cellular stress and/or cell death. Monitoring these processes is crucial to ensure the efficiency and functionality of small-scale cultures or large-scale bioreactors. Enzo offers complete solutions for monitoring a variety of cell processes.

Cell Death

Simplify your Cell Death Analysis

Enzo provides a variety of tools to detect the onset of cell death pathways, including sensitive fluorescent probes for detection of apoptosis, necrosis, and autophagy. These assays can help detect subtle changes in the health of adherent or suspension cell cultures used for production of biotherapeutics, and assess toxicity during drug development.

Autophagy and Apoptosis Assays

Oxidative Stress

Sensitive Assays for Oxidative Stress

Changes in mitochondrial function and glucose metabolism can adversely affect cell line viability, decreasing protein yield in cultured cells and long-term efficacy of cell based therapies. Enzo provides an industry-leading portfolio of kits and reagents for monitoring oxidative stress, including sensitive, high-throughput compatible assays for hypoxia, reactive oxygen species (ROS) and mitochondrial dysfunction.

High-throughput analysis of mitotoxicity

Cell Line Instability

Reliable Detection of Cell Line Instability

Changes in gene expression due to endogenous or transgene copy number loss, or epigenetic suppression can affect cell line stability and yield. Our portfolio of products for detection of cell line instability include fluorescent labeling kits for high-resolution array CGH, RNA amplification and labeling, and DNA methylation.

Superior dye incorporation results in more accurate detection

Small Molecules for Bioprocessing Applications

Cell culture and process optimization can benefit from the addition of several compounds which increase biotherapeutic yield or reduce the risk of cell line instability. Enzo offers an extensive collection of high-purity, cost-effective small molecules and proteins which can be used to optimize the production process both on a small and a large scale.