Pharmaceutical Regulatory Affairs: Open Access

Department of Biomedical Engineering, Sichuan University, Chengdu 610065, China

Publications

• Mini Review   
  Non-microbiological Mycobacterial Detection Techniques in Biopharmaceutical Manufacturing
  Author(s): 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... Read More»
  DOI: 10.37421/2167-7689.2024.13.421

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