Process-Related Residue Assay

process related impurity antibodies introduced into the manufacturing process originate from a variety of stages, including cell-derived impurities, media components, antibiotics, buffer substances, anti-foaming agents., process enhancing agents, enzymes, or leachable compounds from contact materials, etc. These process impurity residuals can impact product safety and critical quality attributes at low concentrations, and require highly specific, sensitive, and robust detection and quantifitation to validate effective removal in process development or validation. Therefore, SHENTEK provides the corresponding quality control solutions for these process residuals, to support process development, monitor batch to batch variations and ensure product release meeting specification Iimits.

Types of Process-Related Residue Assay

Deoxyribonuclease I (DNase) ELISA Kit

Human Serum Albumin (HSA) ELISA Kit (One-step ELISA)

Kanamycin ELISA Kit

Bovine Serum Albumin (BSA) ELISA Kit

Porcine Trypsin ELISA Kit

Trypsin-analog ELISA Kit

Nonspecific Endonuclease (SMNE) ELISA Kit

Glycerol Quantification Colorimetric Kit

Benefits of SHENTEK Process-Related Residue Assay Kits

Assay validation in compliance with pharmacopeia and reports available for regulatory submission.

In compliance with FDA 21 CFR Part 11 GMP regulations.

Compatible with SHENTEK sample preparation and detection kits, stably achieve quality test for biological products.

Ensure accuracy and sensitivity.

If you want to know more about residual seal force testing, residual protein test, weighted residual in particle size analysis and impurities testing for pharmaceutical products, please visit our website.

SHENTEK is dedicated to providing high-quality QC solutions to the biopharmaceutical industry. Our standardized and customized biologics quality control (QC) products cater to various cell species and manufacturing processes.