Affiliation:
1. Sanofi, 1541 Ave. Marcel Mérieux, 69280 Marcy l’Etoile, France
Abstract
Mycobacteria can be one of the main contaminants of biological products, and their presence can have serious consequences on patients’ health. For this reason, the European Pharmacopoeia mandates the specific testing of biological products for mycobacteria, a critical regulatory requirement aimed at ensuring the safety of these products before they are released to the market. The current pharmacopeial reference, i.e., microbial culture method, cannot ensure an exhaustive detection of mycobacteria due to their growth characteristics. Additionally, the method is time consuming and requires a continuous supply of culture media, posing logistical challenges. Thus, to overcome these issues, pharmaceutical industries need to consider alternative non-microbiological techniques to detect these fastidious, slow-growing contaminating agents. This review provides an overview of alternative methods, which could be applied within a quality control environment for biological products and underlines their advantages and limitations. Nucleic acid amplification techniques or direct measurement of mycobacteria stand out as the most suitable alternatives for mycobacterial testing in biological products.
Reference81 articles.
1. Nontuberculosis mycobacterium contamination of a mammalian cell bioreactor process;Boyer;BioPharm Int.,2011
2. Cell Envelope Proteomics of Mycobacteria;Hermann;J. Proteome Res.,2021
3. Environmental sources of rapid growing nontuberculous mycobacteria causing disease in humans;Boeree;Clin. Microbiol. Infect.,2009
4. Mycobacterium chelonei in abscesses after injection of diphtheria-pertussis-tetanus-polio vaccine;Borghans;Am. Rev. Respir. Dis.,1973
5. The burden of mycobacteria species among children from postvaccination abscess in Southern India;Kavitha;Int. J. Mycobacteriol.,2021