Home Biopharma Manufacturing Product Integrity

Product Integrity

The Importance of Monitoring Integrity in Bioprocessing

Safeguarding Product Integrity in Bioprocessing for Uncompromising Quality

Ensuring product integrity during bioprocess manufacturing is vital for safe and effective biopharmaceuticals. Bioprocessing, involving living organisms, demands stringent quality control to meet regulatory standards and prevent adverse effects. This entails continuous monitoring of physical, chemical, and biological parameters throughout production, utilizing various analytical techniques and quality checks. Despite the complexity of biological systems, rigorous monitoring mitigates contamination risks and ensures product consistency, bolstering patient safety and customer confidence.

Upstream Bioprocess

Purification / Formulation

By monitoring aggregation, product stability can be assessed, allowing for the optimization of formulation and manufacturing processes to meet stringent regulatory requirements. This proactive approach ensures the final biopharmaceutical product maintains its integrity, efficacy, and safety.

PROTEOSTAT® Protein Aggregation Assay

Product Information

One-step, ready-to-use solution with no radioisotopes
High sensitivity that correlates with the [3H]-thymidine incorporation assay
High-throughput screening without a solubilization step

Related Product
PROTEOSTAT® Protein Aggregation Standards

Aggregated proteins may lose biological activity, induce immunogenicity, and alter pharmacokinetics, raising concerns about toxicity and reduced bioavailability. Formulation challenges, clinical relevance, and manufacturing hurdles further compound these issues. Addressing aggregation risks is crucial, and innovative solutions like the PROTEOSTAT® protein aggregation assays offer valuable insights.

PROTEOSTAT® Dye Yields Much Brighter Signal

Signal intensity of PROTEOSTAT® aggregate sensing dye compared to other dyes.

Guide to Optimizing Protein Characterization

Bioprocess E-book

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)

Get It Today

PROTEOSTAT® Thermal Shift Stability Assay

Product Information

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

One of the key challenges in biopharmaceutical manufacturing is achieving long-term stability of the product. Biopharmaceutical products are complex molecules that can be sensitive to various environmental factors, such as temperature, pH, and light exposure. Any changes in the product’s stability can affect its efficacy, safety, and shelf-life.

The PROTEOSTAT ® Thermal shift stability assay kit includes a fluorescent dye which detects protein aggregation, so it can be used to monitor protein stability under systematic thermal stress conditions. From the thermal shift assay, a temperature at which the bulk of the protein becomes aggregated can readily be identified.

Based on an innovative molecular rotor dye, the PROTEOSTAT® Thermal Shift Stability Assay is a rapid, simple, and sensitive screening method allowing the end user to investigate the aggregation propensity of proteins by determing the temperature of aggregation.

Thermal Shift Stability Assay Kit

Typical results of the PROTEOSTAT® Thermal Shift Stability Assay are shown for goat anti-mouse IgG (11.2 mg/mL at pH 7.4)

Reference article on GEN Journal

Here and There on Upstream Processing

PEGylated Protein ELISA

Improve Pharmacokinetic Analysis

Product Information

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

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.