药品监管事务：开放获取

Non-microbiological Mycobacterial Detection Techniques in Biopharmaceutical Manufacturing

Abstract

Reuel Beckwith

Mycobacteria, though predominantly known for their role in causing infectious diseases, can also pose significant challenges in biopharmaceutical manufacturing. Traditional microbiological methods often struggle to detect Non-Tuberculous Mycobacteria (NTM) due to their slow growth and unique characteristics. As a result, alternative detection techniques have gained importance in ensuring the safety and quality of biopharmaceutical products. This article explores various non-microbiological mycobacterial detection techniques employed in biopharmaceutical manufacturing, including molecular methods, mass spectrometry and advanced imaging technologies. By leveraging these innovative approaches, biopharmaceutical companies can enhance their ability to detect mycobacterial contamination, thereby mitigating risks and upholding product integrity.