Detection kit for identifying fungal contamination in pharmaceutical products and manufacturing environments. Ensures microbiological quality and safety of biologics.
Manufactured by
Hangzhou, China
OneCheck Biotech Co., Ltd. is a high-tech enterprise dedicated to delivering quality control products and technical solutions for the biopharmaceutical industry. Established in 2021 in Hangzhou, Zhejiang Province, OneCheck focuses on the development and promotion of high-performance bioactive raw materials, innovative medical immunoassays, and advanced molecular detection technologies. Its facilities meet ISO 13485 and ISO 9001 standards and operate under a comprehensive quality management system, ensuring compliance with GLP and GMP guidelines. This guarantees that its technological innovations consistently meet the highest standards for performance and quality. OneCheck has developed a range of advanced technical platforms, including High-Sensitivity Enzyme-Linked Immunosorbent Assay (ELISA), High-Sensitivity Chemiluminescence Immunoassay (CLIA), and Molecular Diagnostic technologies. It also contributed to the formulation of the group standard “Technical Requirements for Antibody to Procalcitonin Detection Kit” (Standard No: T/ZPP 005-2022). OneCheck has made significant advancements in the detection of process protein residues, host cell proteins residues, host cell nucleic acids residues and endotoxin residues. It has maintained close collaborations with leading universities and research institutions, including Shanghai Jiao Tong University, Xiamen University, Xi'an Jiaotong University, and Zhejiang University, as it strives to enhance quality control and drives innovation within the biopharmaceutical sector.
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