Shanghai Medicilon Inc.

Recently, the Analytical Testing Center of Shanghai Medicilon Inc. (Medicilon) successfully passed the on-site assessment by the China National Accreditation Service for Conformity Assessment (CNAS).  This marks that Medicilon's Analytical Testing Center has achieved international recognition standards for its testing results and service quality, laying a solid foundation for the company's continuous deepening in the biopharmaceutical R&D field and expansion into international markets in the future. During this assessment, the CNAS expert team conducted a comprehensive and in-depth inspection of Medicilon's laboratory, covering several key aspects such as the quality manual, procedural documents, operational guidelines, on-site instruments and equipment, and experimental operations.  Following a series of rigorous and professional review procedures, the expert team unanimously concluded that Medicilon's laboratory met the highest requirements of international standa...

Genotoxic impurities refer to compounds or substances that may cause damage to genetic material (DNA or RNA) in biological cells.  These impurities may cause adverse effects such as genetic mutations, chromosomal aberrations, DNA breaks, thereby affecting normal cellular functions and growth, and even leading to diseases such as cancer.  In recent years, the emphasis on genotoxic impurities has continued to increase, triggering more research and discussion on genotoxic impurities.  In the process of new drug development, genotoxic impurities are an important issue that we must address.  Thorough research and assessment of genotoxic impurities are crucial. It ensures patient safety, enhances drug quality, meets regulatory requirements, and is one of the key steps in new drug development. 01 Can the mini-Ames test be used instead of the Ames test? Zeng Bi:  In our experience, during the IND application stage, using the mini-Ames test for impuri...