resDetect™ Kanamycin ELISA Kit (Residue Testing) (High sensitivity)

Materials Provided

Product Overview

resDetect™ Kanamycin ELISA Kit adopts the competitive ELISA method, dedicated to detecting and quantifying Kanamycin residues in biopharmaceutical matrices. It applies to key raw materials and preparations. As a widely used broad-spectrum antibiotic in biopharmaceuticals, Kanamycin is often combined with penicillin (forming a "double antibody" system) to prevent Gram-negative bacterial contamination during cell expansion. However, residual Kanamycin in final products may cause drug resistance, allergies, or interfere with downstream assays—strict residue control is thus critical for GMP compliance.Calibrated against NIFDC-certified standards, the kit features detection range and sensitivity tailored to ICH Q9 and Chinese Pharmacopoeia limits. It provides reliable quantification for drug development stages, including preclinical optimization, CMC quality control, and final product batch release.Beyond biopharmaceuticals, it also serves as a universal tool for Kanamycin quantification in cell bank qualification, raw material inspection, and process control—helping enterprises meet international regulatory requirements and ensure product safety.

Application

For the detection and quantitative determination of Kanamycin residues in plasmid DNA raw materials for cell and gene therapy.

It is for research use only.

Storage

1. Unopened kit should be stored at 2℃-8℃ upon receiving.

2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process