Process related impurities 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 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.
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.
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